Johnson & Johnson nabs another combo approval for myeloma star Darzalex

Late last year, Johnson & Johnson widened Darzalex’s reach with some combo approvals. And now, it’s adding to that roster. The medication has snagged a green light for use in tandem with chemo drug dexamethasone and Celgene’s Pomalyst for multiple myeloma patients who have already tried at least two prior therapies, including fellow Celgene med Revlimid and a proteasome inhibitor such as Takeda’s Velcade, J&J partner Genmab said Friday. The approval comes based on a phase 1 study that showed the Darzalex regimen could trigger a response in 59% of patients, with those responses lasting a median 13.6 months. For J&J and Genmab, it’s just the latest Darzalex combo to win a go-ahead from U.S. regulators. Back in November, the team snagged a thumbs up for Darzalex—alongside dexamethasone and either Revlimid or Velcade—as a treatment for patients who had received just one prior therapy. That regulatory win both opened up Darzalex’ target population—bringing in patients who tend to stay on therapy for longer—and helped even the score between Darzalex and fellow myeloma newcomers Ninlaro from Takeda and Empliciti from AbbVie and Bristol-Myers Squibb, both of which already had FDA clearance in second-line cocktails.

Clovis plots Rubraca label expansion with new phase 3 data for its PARP inhibitor

Just months into the launch of its PARP inhibitor Rubraca, Clovis Oncology on Monday unveiled positive phase 3 results that the drugmaker hopes can win its ovarian cancer drug a big label expansion in its three-drug horse race with AstraZeneca’s Lynparza and Tesaro’s Zejula. In a phase 3 study dubbed Ariel3, Rubraca improved progression-free survival for each of three patient populations studied, meeting primary and secondary endpoints in the 564-patient trial. For the primary endpoint, investigators analyzed women with the BRCA mutation, HRD-positive patients and the entire study population. Rubraca significantly bested placebo for each of the groups. Clovis plans to submit its data to the FDA within four months, aiming for an expansion into second-line and later maintenance treatment for ovarian cancer patients. Currently, Rubraca is approved to treat ovarian cancer patients who have the BRCA gene mutation and who’ve already had two or more chemotherapies.

Novartis scores EU approval for biosim of Roche’s blockbuster Rituxan

Roche faces bad news today for its third-top selling drug Rituxan after its cross-town rival Novartis won European approval for its biosimilar. Rixathon, the copy from Novartis’ Sandoz unit, was approved to treat both blood cancers, including non-Hodgkin’s lymphoma, and immunological diseases such as rheumatoid arthritis. Sandoz follows Celltrion into the market, which in February won approval of its Rituxan biosimililar, Truxima. For Novartis, Rixathon is the fourth biosimilar approved in Europe and one more step in its plan to be a dominant player in the the field. It was the first to win approval of a biosimilar in the U.S. and has plans to have 11 biosimilar regulatory filings in the can by the end of this year, including Rixathon in the U.S.

Seattle Genetics stops all trials of ’33A blood cancer drug after patient deaths

Seattle Genetics has called a halt to all clinical testing of vadastuximab talirine (SGN-CD33A) after seeing a higher rate of patient deaths with the drug in a phase 3 trial. Several earlier-stage trials of the CD33-targeting antibody-drug conjugate were halted by the FDA last December on safety concerns, mainly relating to possible liver toxicity. Now, the CASCADE registration study in acute myeloid leukemia (AML) and another phase 1/2 study in myelodysplastic syndrome have also been stopped, leaving the program looking decidedly shaky and driving the company’s shares down more than 11% premarket. There was no evidence of liver damage in CASCADE, but a higher rate of deaths—including fatal infections—were seen with vadastuximab talirine compared to placebo in the study. It’s a big blow to the company as well as AML patients and their carers, particularly as data reported at the American Society of Hematology meeting last December showed a complete remission rate of 70% with the drug.



J&J’s Invokana matches Jardiance’s 14% reduction in major CV events

There’s officially another heart-helping SGLT2 on the block. But this one brings some varied benefits—and amputation risks—along with it. In a cardiovascular outcomes trial, Johnson & Johnson’s Invokana matched up to Eli Lilly and Boehringer Ingelheim’s Jardiance at cutting a composite measure of CV risks, posting a 14% reduction. Those paying close attention may recognize that 14% is the same mark Jardiance hit back in 2015. But that’s where the similarities between the two data sets end. Unlike Jardiance, which failed to make a significant difference in the risk of heart attack or stroke, Invokana pared down risks in both measures—by 15% and 10%, respectively. On the flip side, though, while J&J’s entrant was able to slash the risk of cardiovascular death by 13% that number pales in comparison with Jardiance’s 38%—a figure that now has a place on the Lilly/BI med’s label.

Novo’s Xultophy beats basal-bolus insulin at cutting hypoglycemia, spurring weight loss

Novo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s Soliqua. New basal-bolus topping data, though, could give the medicine a leg up. Xultophy—which marries Novo’s newest basal insulin, Tresiba, with its top-selling GLP-1 med Victoza—beat a “gold-standard” insulin therapy at helping Type 2 diabetes patients avoid hypoglycemia and weight gain, common side effects of insulin. And it did that while matching the older basal-bolus treatment’s ability to cut blood-sugar levels, a new study showed. Presented on Saturday at the American Diabetes Association’s annual meeting, the trial pitted Xultophy against basal-bolus therapy with Sanofi’s standard basal insulin, Lantus, and Novo’s own mealtime insulin NovoLog. Xultophy took 66% of patients down below a 7% A1C target, similar to the 67% of patients who reached the mark with the basal-bolus duo.

Lilly and BI, following their SGLT2 rivals, plot kidney disease study for Jardiance

Eli Lilly and Boehringer Ingelheim have reason to believe their SGLT2 inhibitor, Jardiance, may improve outcomes for chronic kidney disease patients—so they’re putting the medicine to the test. On Monday, in the middle of the American Diabetes Association’s annual meeting, the pair announced plans to run a new outcomes trial specifically aimed at assessing Jardiance in kidney disease patients, both with and without diabetes. The companies based the decision on data from Empa-Reg Outcome, the cardiovascular outcomes trial that made headlines back in 2015 by showing Jardiance could cut the risk of major CV events by 14% and the risk of cardiovascular death by 38%. At last year’s ADA meeting, the drugmakers unveiled a new analysis of the study showing that Jardiance had posted a 55% reduction in the initiation of renal replacement therapy, such as dialysis.

Novo’s Tresiba matches Sanofi rival Lantus in CV safety study

Going up against Sanofi blockbuster Lantus is no easy task, but that’s exactly what Novo Nordisk and its long-acting insulin Tresiba have to do. Thanks to new data, though, the Danish drugmaker can safely say its newcomer poses no increased heart risks—and it has some advantages over its rival, too. On Monday at the American Diabetes Association annual meeting, Novo unveiled a 7,637-patient study showing that high-risk Type 2 diabetes patients taking Tresiba were no more likely to suffer a major cardiovascular event—such as heart attack or stroke—than those using Lantus were. It’s good news for Novo, which kicked off the trial—dubbed Devote—after the FDA turned away Tresiba in early 2013. In sending Novo back to conduct a CV trial, the agency spurned the advice of an advisory panel, which had recommended a study post-approval instead of beforehand.



Dendreon touts T-cell response data for prostate cancer vaccine Provenge

Dendreon has had no shortage of challenges with Provenge since winning FDA approval for the groundbreaking prostate cancer vaccine back in 2010. Years later, the company has unveiled new data showing the med generates a killer T-cell response—and the strength of that response correlates with overall survival. In a Monday poster session at the American Society of Clinical Oncology’s annual meeting, Dendreon showcased the new data showing that Provenge elicits a T-cell response to the immunizing antigen A2024 and to the target antigen prostatic acid phosphatase on prostate tumor cells. The responses were seen as early as six weeks after patients received Provenge and lasted for a minimum of six months, according to the company. Men with both hormone-sensitive prostate cancer and those with metastatic castrate-resistant prostate cancer (mCRPC) experienced the responses, which correlated with improved overall survival.

Johnson & Johnson’s Zytiga slashes death risk by 38% in earlier-stage prostate cancer patients

Johnson & Johnson may soon be able to move prostate cancer med Zytiga into an earlier disease stage, thanks to game-changing new data that rolled out on Saturday at the American Society of Clinical Oncology (ASCO) annual meeting. Zytiga, in tandem with prednisone and androgen deprivation therapy, trounced an ADT-plus-placebo duo at improving survival among patients with high-risk metastatic hormone-naïve prostate cancer, cutting the risk of death by 38%, J&J said Saturday. Median overall survival for the Zytiga arm wasn’t reached, while the placebo arm posted an average of 34.7 months. And that wasn’t all. Zytiga also slashed the risk of progression or death by 53%, more than doubling the average time to one of those events from 14.8 months on ADT alone to 33 months on the J&J med.

AstraZeneca’s Lynparza posts 42% survival win in breast cancer

Back in February, AstraZeneca announced that its Lynparza had become the first PARP inhibitor to find success outside of ovarian cancer, posting positive results among breast cancer patients. And Sunday, the British drugmaker revealed just how positive those results were. In a phase 3 study comparing the medication with standard-of-care chemo in patients with HER2-negative breast cancer and BRCA1 or BRCA2 mutations, Lynparza pared down the risk of disease worsening or death by 42%, AZ said at the American Society of Clinical Oncology annual meeting. Tumors shrank in about 60% of patients treated with Lynparza, versus just 29% of those in the chemo arm of the study. And importantly, the med was “effective” among patients with triple-negative breast cancer, which has proven notoriously difficult to treat.

Pfizer’s two-time loser dacomitinib finally wins in phase 3 against AstraZeneca’s Iressa

Pfizer’s EGFR lung cancer candidate, dacomitinib, doesn’t have a pretty past. But the New York drugmaker has finally rung up a phase 3 victory. On Monday, the American Society of Clinical Oncology announced that dacomitinib had topped AstraZeneca’s Iressa in delaying cancer growth in newly diagnosed patients, slashing the risk of progression or death by 41%. With dacomitinib, trial participants went a median 14.7 months without their cancer worsening, compared with 9.2 months on Iressa. Both drugs are part of the tyrosine kinase inhibitors (TKI) class of meds. It’s the first positive set of phase 3 results for the Pfizer prospect, which flopped in two late-stage studies back in early 2014. In one, the med failed to improve progression-free survival compared with Roche’s Tarceva, and in the other, also versus Tarceva, it couldn’t significantly increase overall survival.

Roche’s Alecensa trounces Pfizer’s Xalkori in head-to-head ALK matchup

Novartis’ Zykadia just won the right to challenge Pfizer’s Xalkori for the first-line ALK-positive lung-cancer crown. But the way Roche sees it, that crown is Alecensa’s for the taking, as soon as it can nab an FDA approval, too. Monday at the American Society of Clinical Oncology annual meeting, the Swiss drugmaker’s contender posted data showing it could beat Xalkori at cutting down the risk of disease worsening or death by more than 53%. Both drugs are targeted at lung tumors with an ALK gene rearrangement. Alecensa also led when it came to preventing brain metastases, which are more common among ALK-positive patients because it’s an aggressive tumor. Patients in the Alecensa group recorded just a 9% incidence of brain metastases at the 12-month mark, while 41% of patients in the Xalkori arm developed them. Overall, the data are really clear in the sense that this will become the new standard of care for first-line.



Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications

The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmakers upped the ante with positive new data for their contenders. At the American Thoracic Society’s annual meeting, Roche rolled out new analyses of phase 3 data showing that Esbriet, when compared with placebo, could cut the risk of death by 72% among patients with more serious lung function impairment, reduce patient-reported breathlessness among sufferers with moderate impairment and decrease the rate of respiratory-related hospitalizations among patients. Competitor Boehringer, though, had good news to report from new analyses of it own. Pooled phase 3 data showed that Ofev patients were, at 36.8%, twice as likely as those on placebo to experience an improvement—or experience no decline—in lung function, the German pharma said. Results also showed that Ofev didn’t increase the incidence of major adverse cardiovascular events among high-risk patients when compared with placebo. Both drug makers are looking for an edge in what so far has proved to be a competitive market race.

Trio of patients sue Pfizer, Bristol-Myers, claiming they soft-pedaled Eliquis bleeding risks

Just two weeks after convincing a judge in New York to toss a liability case over Eliquis bleeding risks, Pfizer and Bristol-Myers Squibb face three new suits in the same state over claims their big-selling anticoagulant ended up hurting patients. Filed this week in New York State court, the suits say Pfizer and BMS “negligently and fraudulently” represented their blockbuster med as “safe and effective for its indicated uses.” The companies “concealed their knowledge of Eliquis’ defects” from prescribing physicians and the larger public, the lawsuits claim. After several months on Eliquis, the plaintiffs developed a variety of bleeding problems—bilateral subdural hemorrhages in one case, a subdural hematoma in another and postoperative bleeding, acute blood loss anemia and a hematoma in the third, according to the lawsuits. All of them required lengthy hospital stays. Pfizer and BMS “believe that the claims in these cases lack merit,” according to a Pfizer spokesperson.

New FDA commissioner Gottlieb unveils price-fighting strategies

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices. Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year. At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies. In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.

EpicGenetics looks north to expand landmark fibromyalgia study

For four years, EpicGenetics has been selling its diagnostic for fibromyalgia in the U.S. Now it can list Canada among its international markets for the test. The company says approval and launch in Canada will help it push forward with an ambitious R&D program that is trying to decipher the underlying genetic basis for the chronic and painful condition, which affects millions of people worldwide. The Santa Monica, California, company made waves when its FM/a blood test for fibromyalgia secured a CLIA certification and became the first test available for fibromyalgia, which often goes undiagnosed because its symptoms can be so diverse. Aside from pain it can be accompanied by fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function.



Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies

Rocked by a corruption scandal in Korea and facing a kickbacks probe in Greece, Novartis says it’s strengthening and simplifying its global ethics and compliance approach. The Swiss drug giant is aiming to shift from policing to coaching, with a compliance unit focused on helping local units make the right decisions. Novartis also wants to simplify its policies so they are easy to understand. Last month, Korean authorities handed out a $50 million fine and suspended coverage on several Novartis meds in relation to a bribery probe in the country. Novartis employees conducted a kickbacks scheme through medical journal-sponsored meetings, with the total spent on bribes estimated to be $2.3 million, according to officials.

China’s latest Western-style FDA tweak puts orphan drug approvals in the fast lane

China’s FDA, long criticized for its cumbersome and slow drug-review process, is offering to grant conditional OKs for orphan meds already approved abroad, even without in-China trial data. The new orphan drug move is one in a series of new proposals posted online May 11. China’s FDA is once again planning major changes to its clinical trial and drug approval policies, further aligning them with its Western counterparts. A key feature is the new “conditional marketing authorization” for orphan meds. The CFDA is offering (Chinese) to grant conditional approval for meds that treat life-threatening conditions where significant unmet medical needs exist, if early- or mid-stage data can predict the drugs’ clinical benefits. This policy resembles the EMA’s “conditional marketing authorization” and the U.S. FDA’s “breakthrough therapy” program, which itself is just short of 5 years old.

Dendreon eyes real-world data boost for lagging prostate cancer med Provenge

Years after winning a hotly anticipated FDA approval for its cancer immunotherapy Provenge—and struggling to build sales of the prostate cancer med—Dendreon has racked up some real-world survival data it hopes can help. At the American Urologic Association’s annual meeting, the company presented real-world findings showing a survival benefit especially pronounced in African American patients with metastatic castrate-resistant prostate cancer (mCPRC). African-American Provenge patients lived a median 37.3 months after treatment compared with 28 months after treatment for Caucasian patients. The data were consistent with the clinical trials Dendreon used to win Provenge approval back in 2010, according to the company, bought out by China’s Sanpower last year.

Amgen adds online cancer team narratives to Neulasta Onpro push

Cancer patients and their care teams are taking center stage in Amgen’s newest online campaign. The Neulasta Onpro effort, dubbed Neulasta Onpro Narratives, highlights patients’ and professionals’ cancer stories to encourage conversations, specifically about the risk of infection from low white blood cell counts—a risk Neulasta is approved to reduce. Sharing the personal experiences can help raise awareness and encourage patients to discuss the potential risk with their healthcare professional, as per company sources. The online campaign comes just over a year into Amgen’s first Neulasta Onpro-specific TV ad, titled “Support at Home,” which began running last March. Amgen has spent more than $38 million on national TV airings of the ad, according to data from real-time TV ad tracker The Onpro DTC campaign includes similarly themed print ads.


Lilly moves forward with biologics plant expansion in Ireland

Eli Lilly has confirmed that it will move forward with plans to add a manufacturing line at its site in Kindsdale, County Cork in Ireland. The construction might begin in coming months and commissioning will begin in 2019. The expansion is expected to add about 130 workers to the site by 2020. As negotiations are underway, specifics of the investment are not being released. Earlier reports put the cost at about €200 million. The site also does API production for a host of small molecule drugs. Last year, the company said it would invest nearly $40 million (€35 million) to build a continuous manufacturing facility. Tremors of concern spread through Ireland in February when Lilly said it halted preparations for the project. That ignited speculation among some politicians that Lilly might divert funds to the U.S. after President Trump held a meeting with pharma execs in which he urged them to invest in U.S. manufacturing.

Brazilian authorities raid Alexion office in another sales-practices probe

Alexion’s sales practices are under the lens again. Just four months after concluding its top brass inappropriately pressured staff to pad Soliris sales in the U.S., Brazilian authorities raided the company’s Sao Paulo offices as part of an investigation into its marketing there. Brazil’s police are probing whether the Connecticut-based biotech, helped by Brazilian patient association Associacao dos Familiares, Amigos e Portadores de Doenças Graves (AFAG), subsidized lawsuits for patients to gain access to an Alexion drug through Brazil’s national health system. AFAG, to which Alexion has said it gives financial support, was also searched. Law enforcement officials have turned up evidence showing that some of the lawsuits—which number more than 900 in the last six years—were fraudulent and used fake diagnoses to help reel in patients. Through those lawsuits, Alexion drummed up $400 million in sales from the Brazilian government in that time period, the warrant request says.

Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning

Last year, the FDA called for stronger heart-failure warnings on the label of AstraZeneca Type 2 diabetes med Onglyza. And now, AstraZeneca and former partner Bristol-Myers Squibb are being hit with 14 lawsuits related to the med’s heart failure risks. The suits, filed in the District of New Jersey, claim the drug makers failed to warn users that Onglyza and related combo product Kombiglyza XR can cause cardiac arrest, congestive heart failure, and death. The pharma pair began marketing Onglyza in 2009 before conducting clinical trials to see whether it upped patients’ cardiac risks, the plaintiffs allege, ignoring 2008 FDA guidance that urged companies to “demonstrate that” new therapies “will not result in an unacceptable increase in cardiovascular risk.” AstraZeneca, for its part, “is confident in the safety and efficacy of Onglyza, when used in accordance with the FDA-approved label, which has been established through clinical trials. We will vigorously defend against the allegations made by the plaintiffs,” a spokeswoman said in a statement.

PhRMA expected to weed out some members with new R&D rules

PhRMA, which has already rid itself of a couple of members who had brought unwanted attention to the industry for their practice of jacking up prices, will vote on new membership rules that are expected to trim its membership, and hopefully criticism, even further. PhRMA spokeswoman Holly Campbell said today she could not discuss details of the new rules ahead of tomorrow’s vote. The group began reviewing its bylaws to focus on “research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients,” as public criticism over drug pricing has escalated. PhRMA’s new rules will require members to invest at least $200 million a year on average over three years of research and development. Their R&D budgets would also have to equal at least 10% of their global sales.


FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer

Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, the patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food. Brigatinib has an orphan drug designation for this indication and Takeda received an Accelerated Approval of the drug based on tumor response rate and duration of response. An Accelerated Approval means Takeda can market the drug now but additional studies (i.e., a phase 3 clinical trial) may be needed by the FDA moving forward.

AZ nabs FDA nod for bladder cancer for checkpoint med Imfinzi

AstraZeneca got its first FDA approval with its checkpoint inhibitor Imfinzi (durvalumab), as the British pharma giant picked up an accelerated green light in urothelial carcinoma. This makes the company the third Big Pharma player to enter the advanced bladder cancer space with a PD-1/PD-L1 inhibitor. Imfinzi will take on established player Tecentriq from Roche, which hit the scene last May, and Opdivo, the Bristol-Myers Squibb entrant that won its bladder go-ahead in February. Merck is still chasing a bladder cancer nod for its contender, Keytruda. Imfinzi, though, will roll out at a higher price point than its nemeses; as estimated average monthly cost of the med will be $15,000, compared with its rivals’ $12,500. The approval comes based on a single-arm, 182-patient trial, which produced an overall response rate of 26.3% among the 95 patients with high PD-L1 scores. As Tecentriq does, Imfinzi goes hand in hand with a complementary diagnostic from Ventana that assesses PD-L1 levels in tumors.

Novo Nordisk to settle med-whistleblower suit

Novo Nordisk has moved to settle a whistleblower lawsuit alleging the company ran a “white-coat marketing scheme” to pump up sales of NovoLog, Victoza and Levemir. According to the suit, recently unsealed as part of the settlement process—Novo Nordisk partnered with a clinical education company, Healthstar’s PT, to set up a program dubbed Changing Life with Diabetes. The group hired and trained certified diabetes educators (CDEs), according to the suit, which was brought by two former managers and more than two dozen states. The whistleblowers claim that since 2006, Novo ran the program to gain crucial access to physician practices, where CDEs would provide thousands of dollars’ worth of educational programs and materials. The idea behind the program, according to the suit, was to induce prescribers to write scripts for Novo’s diabetes meds by offering such services. Due to this, U.S. pricing pressures have taken a toll at Novo lately, forcing the company to cast off 1,000 staffers last fall.

Novartis to pay $50M, lose some drug coverage in Korean bribery probe

For more than a year, Novartis has been under investigation in Korea for allegedly bribing doctors to pump up sales. Now, the Swiss drug giant is learning about its punishment in the country as authorities there decided to issue a fine of nearly $50 million. On a preliminary basis, Korea’s Ministry of Health & Welfare (MHW) has fined Novartis 55 billion Korean won, approximately $50 million, and suspended reimbursement of Exelon and Zometa for three months. The final decision is expected by the end of May. Previously, authorities were weighing a suspension of the company’s big-selling cancer med Glivec, according to The Korea Times, but feared that move would leave some 3,000 to 5,000 chronic myeloid leukemia patients with no other options.


Samsung biosim nod sets J&J’s Remicade up for tough fight

Samsung Bioepis won FDA approval late Friday for its Remicade substitute, Renflexis (infliximab-abda), becoming the the second biosimilar to threaten that brand in the U.S. Not an unexpected event, and the launch isn’t expected until October because of biosimilar rollout rules. But six months pass quickly in the pharma world, and analysts see the second biosim emboldening payers to press for bigger rebates and pushing the three contenders to get more aggressive about winning share—or protecting it, as the case may be. Add into the mix the fact that Merck & Co. has marketing rights and the rivalry looks even more interesting. Soon, Remicade will have companies experienced on both sides of the biosimilar-brand competition making a run at its U.S. sales.

Lilly’s cancer med abemaciclib hits survival mark, but can it stand up to Ibrance and Kisqali?

Eli Lilly’s chances of snagging an abemaciclib approval as wide as those of its rivals are looking even better. In a phase 3 trial of the drug in previously untreated patients with HR-positive, HER2-negative breast cancer, abemaciclib nailed its primary endpoint, demonstrating significant improvement in progression-free survival. The performance follows up on last month’s positive results from Lilly’s other key trial, a test in patients whose cancer had come back after a first round of treatment. With those two sets of positive data in hand, the Indianapolis drugmaker is “assured of a product label with the same breadth” as that of Pfizer’s Ibrance and Novartis’ Kisqali, Bernstein analyst Tim Anderson predicted in a Monday note to clients. But that may not be enough to ensure abemaciclib’s success.

BioMarin sees ‘high end’ pricing on Brineura ahead of FDA decision

Children with a rare, devastating brain disease may soon have their first treatment option in BioMarin’s Brineura, up for an FDA decision later this week. And it’s likely to instantly join the ranks of the world’s most expensive meds if approved. Experts from the European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday endorsed the drug to treat Neuronal Ceroid Lipofuscinosis Type 2 disease, a form of Batten disease. The EMA usually green-lights drugs that have CHMP recommendations, but it isn’t required to do so. In the U.S., Brineura is set for a decision date the coming Friday. Execs at BioMarin said the company is in label discussions with the U.S. agency.

Biogen’s Spinraza scores later-onset SMA data for stepped-up push with payers

Hoping to win over careful payers, Biogen has new data to support its superpricey spinal muscular atrophy (SMA) drug Spinraza. In new phase 3 data from a study in children with later-onset SMA, patients on Spinraza “demonstrated a highly statistically significant and clinically meaningful improvement in motor function” over their counterparts who received a sham treatment, the Cambridge, Massachusetts-based biotech said in a Monday release. Biogen won approval for the med back in December and sparked criticism by pricing the groundbreaking injection at $750,000 for the first year, a figure that falls to $375,000 for subsequent years. In an earlier study of infantile-onset (type 1) patients, a higher percentage of children on Spinraza survived compared with untreated patients. Data from the newly finished study, Cherish, weren’t available at the time, but the FDA nonetheless approved the med for treatment of all SMA types.

Klick Labs creates empathy-boosting Parkinson’s simulator

Klick’s digital innovation unit Klick Labs created a device to transmit tremors from a Parkinson’s patient to someone who doesn’t suffer from the disease, to dramatically illustrate its effects. That’s empathy-creation in action, and the basis for a planned clinical study about the ways empathy can improve patients’ health. For pharmas, it’s a potential tool for sales-rep training. And the device can show differences between patients who are treated and those who aren’t, Klick says, opening up the potential for other applications. The programmable SymPulse device connects a Parkinson’s patient to a second person. A sensor on the patient digitizes and transmits tremors or muscle contractions, using electrical muscle stimulation, to a device worn by the non-patient. The result? The receiver can feel the exact same things the patient does. Klick refers to it as “tele-empathy.”


Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag

As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA ‘breakthrough’ tag for its eagerly awaited JULIET trial. This latest label, which can speed things along for Novartis’ CTL019 (tisagenlecleucel), is for relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). This is the most common form of lymphoma and accounts for around 30% of all non-Hodgkin lymphoma cases. The drug already has a breakthrough tag for r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients, and was given a priority review at the end of March. Novartis is in a race with Kite Pharma, a specialist CAR-T biotech working on axicabtagene ciloleucel (a.k.a. KTE-C19), which a day after Novartis got its priority review, said it had finished its rolling submission with the FDA for a BLA of its med as a treatment for patients with r/r B-cell non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant.

Shire, armed with new rare disease patent, aims to block CSL’s Haegarda launch

Anticipating an FDA approval later this year for a promising hereditary angioedema med from CSL, Shire has taken a preemptive strike at the Australian drugmaker. In a new lawsuit, it’s asking a court to block the launch. Filed last week in U.S. District Court in Delaware, Shire’s lawsuit contends that CSL is gearing up to launch a drug, Haegarda, that will step on its own brand-new patent, issued just last week. Shire’s attempt to block the launch follows Amgen’s successful bid for an injunction against Sanofi and Regeneron, which make Praluent, a PCSK9 cholesterol drug that rivals its own Repatha. That injunction, if upheld on appeal, would push Praluent off the market, unless the two sides agree on royalties. It would be the first such move against a rival drug in almost a decade.

Pfizer’s Xeljanz stands to win from Lilly’s baricitinib stunner

Eli Lilly & Co.’s Olumiant rejection surprise Friday has one obvious beneficiary: Pfizer and its rival rheumatoid arthritis med, Xeljanz, already set to break the blockbuster barrier this year. That’s because Xeljanz is the sole oral JAK inhibitor now FDA-approved for rheumatoid arthritis. Olumiant (baricitinib) would have been the second, and some analysts predicted the Lilly med—licensed from Incyte for $90 million up front, plus milestones and marketing arrangements—might beat Xeljanz on the efficacy side. Baricitinib had been pegged as one of 2017’s biggest launches. Now, Olumiant isn’t likely to roll out for a couple more years, giving Xeljanz more time to solidify its first-to-market lead.

Payer snubs PTC’s Emflaza, signaling pricing trouble ahead of launch

PTC Therapeutics faces an uphill battle to extract brand-level pricing and sales with its new, and controversial, DMD drug Emflaza if a new policy report out of Washington state is any indication of payer sentiments. Washington State’s Health Care Authority, the largest purchaser in the state, published a review of the newly approved med compared to the much cheaper prednisone, currently the most commonly used steroid by Duchenne muscular disorder patients. Emflaza, a decades-old steroid itself, recently won FDA approval under Marathon Pharma’s ownership. But that drugmaker’s decision to attach an $89,000 price tag to a med that’s available elsewhere for much cheaper created instant backlash.

Maryland lawmakers pass a bill aimed at stopping ‘unconscionable’ drug pricing

Taking the fight against high drug prices into their own hands, Maryland lawmakers passed a bill aimed at taking on “unconscionable” pricing practices with their sights set squarely on generics. But drug makers are blasting back, hoping to convince the governor not to sign it into law. Under the legislation, the Maryland Medical Assistance Program will notify Attorney General Brian Frosh if a generic drug’s price spikes by 50% in one year or if its price increases while there are three or fewer companies making the med, among other potential violations. Then, the attorney general is able to request a report from drug makers detailing production costs, the rationale for the price hike and efforts to expand access. If Frosh determines the company committed a violation of the pricing law, he can request that a circuit court force it to roll back the price hike and return money to consumers.


Malaysia calls for phase 4 Dengvaxia study before considering full approval

Already struggling to meet initial expectations, Sanofi Pasteur’s dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical Regulatory Agency’s Drug Control Authority, which conditionally approved the vaccine, said in a notice that if the study fails to verify the clinical benefit, DCA may withdraw Dengvaxia’s registration. The French vaccine maker will conduct the two-year trial jointly with the country’s Ministry of Health, aiming to further assess the vaccine’s effectiveness and safety. Before the readout, the vaccine will only be available to eligible trial volunteers 9 to 45 years old. It won’t be covered by Malaysia’s National Immunisation Programme, meaning that participants will need to pay to get vaccinated.

Bristol-Myers’ Opdivo racks up latest NICE rejection, this time in head and neck cancer

Bristol-Myers Squibb’s Opdivo hasn’t even won marketing approval for head and neck cancer in England and Wales yet, but their cost watchdog is already shutting it out. The National Institute for Health and Care Excellence on Tuesday introduced the latest in a series of setbacks for the BMS immuno-oncology hotshot: draft guidance that doesn’t recommend it as a head and neck cancer therapy. The med’s costs—£439 per 40-mg vial and £1,097 per 100-mg vial, less a confidential discount agreed to with Bristol-Myers—“were considered to be very high in relation to its benefit to be recommended for routine NHS use at present,” Carole Longson, director of NICE’s health technology evaluation center.

FDA issues another Mylan plant in India a warning letter

Less than two years after being given a warning letter by the FDA for problems at three plants it got in its buyout of a sterile injectables specialist Agila Specialties, another Mylan plant in India has been issued a warning letter for ongoing data integrity issues. In the warning letter, issued last week and posted by the FDA today, the agency said investigators continued to find issues with batch testing results disappearing from computers when failed tests were involved. The observations were based on an inspection of the finished pharmaceutical plant in Maharashtra, India. It noted that even though the facility invalidated 101 of 139 initial out-of-specification (OOS) assay results, about 72%, employees never thoroughly investigated to find the root cause of the issues and didn’t include them in the results reported to the agency.

Mexican regulator undermines Teva’s Rimsa fraud claims with ‘all clear’ memorandum

Teva contends that Mexican generics buy Rimsa sold defective, illegal products and lied about it, duping not only itself as buyer, but regulators and the public as well. But a new memorandum from Mexico’s drug watchdog doesn’t help its case. According to a March 13 document seen by The Times of Israel, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) found no “unexpected adverse effects” among Rimsa’s 147 products and has located authorization for all of them within its archives. Sixteen COFEPRIS checks on Rimsa dating back to 2009 also failed to turn up any issues that could pose health risks, and the body found documentation provided by Rimsa to be “truthful and correct.” The conclusions don’t exactly support Teva’s legal claims that Rimsa withheld discrepancies between manufacturing processes and descriptions in product registrations filed with regulators.

Mission bags Fox Foundation grant for Parkinson’s program

Mission Therapeutics and the University of Oxford have landed a grant to fund testing of USP30 inhibitors. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is putting up the money to enable Mission to test its USP30 inhibitors in stem cell-derived Parkinson’s disease models. MJFF is funding the research in an attempt to validate USP30 as a target for the treatment of Parkinson’s. By inhibiting USP30 in malfunctioning mitochondria, the scientists stand to show whether the therapeutic approach may improve the operation of the organelles and neuron health. And there is an expectation this will enable the identification of biomarkers of USP30 that will prove useful in subsequent clinical development.