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.


Biogen triumphs in latest Tecfidera patent dispute

Biogen has prevailed in a patent squabble with Denmark’s Forward Pharma over multiple sclerosis med Tecfidera—but the decision may not actually help the Big Biotech steer clear of generic rivals. The Patent Trial and Appeal Board (PTAB) ruled Friday that Forward could not declare patent infringement by Biogen. The verdict kept Biogen’s Tecfidera IP intact and secured exclusivity through 2028. It’s an outcome that is worth about $5 of upside to Biogen’s stock. In January, Biogen hedged the outcome of the Forward challenge by agreeing to a $1.25 billion settlement with the Danish pharma. The deal would have allowed it to license Forward’s IP to shield Tecfidera had the PTAB ruling not gone its way. But now that its own IP shield can stay, Biogen will not need to use Forward’s IP, and it also will not owe a royalty contingent for that settlement worth 10% of U.S. sales.

Lilly, Pfizer, Ipsen back Sanofi and Regeneron in PCSK9 patent appeal, AbbVie doesn’t

Big Pharma is enthralled with the Amgen vs. Sanofi patent fight, as its outcome could affect their in-development meds. Amgen, which makes the cholesterol-fighting Repatha, is asserting an antibody patent that, if upheld, could give the California biotech the power to push Sanofi and Regeneron’s rival PCSK9 drug off the market. And it’s a type of patent that has the potential to allow Amgen—and other drugmakers in other fields—to stake out a claim to an entire class of therapies, or so Sanofi’s legal team said in a recent phone conference with reporters. And that’s why drugmakers have been weighing in with amicus curiae briefs at the U.S. Appeals Court for the Federal Circuit, which hears all patent appeals—Pfizer, Eli Lilly and Ipsen among them. The lone outlier, at least so far is AbbVie. AbbVie’s brief contends that antibodies are expensive to develop, and without strong patent protections that limit competition, wouldn’t be worth the expense. Patent protection may mean drugs cost more in the short run, but that’s the price of developing new and complex biologic treatments, the brief states.

Court nixes Acorda patents, teeing up Ampyra generics

Acorda Therapeutics’ IP protection on Ampyra may have held up against pharma patent challenger Kyle Bass at the U.S. Patent and Trademark Office, but it didn’t do the same in court. A U.S. District Court stamped out four of the company’s five patents on the med for multiple sclerosis patients, dubbing them invalid on the grounds of obviousness. It kept just one—a sustained-release patent set to expire in mid-2018—meaning generic competition in 2018 is “realistic,” Leerink Partners analyst Paul Matteis wrote in a note to clients. Ardsley, NY-based Acorda, unsurprisingly, plans to appeal the decision, but it’s not going to sit back and wait for an about-face in court. The company has developed contingency plans for early Ampyra generics, and it “will provide an update after finalizing the implementation timeline”.

Mylan EpiPen recall goes global but company says it has plenty of replacements

A recall of potentially malfunctioning EpiPens that Mylan first announced for Europe, Japan and Asia has now gone global, including the U.S., with the company retrieving tens of thousands more. Mylan, however, says it has plenty of replacements to avoid any interruptions in supply. The drugmaker announced the expanded recall of late Friday after the markets closed. According to the FDA, Mylan is voluntarily recalling the 0.3 mg and 0.15 mg strengths of EpiPen and EpiPen Jr. Auto-Injector because of a problem that may keep them from activating. The recall does not include any of its Mylan’s new authorized generic EpiPens. The first recall was for Japan, Australia and some markets in Europe. Now it has been expanded to the U.S. as well as additional markets in Europe, Asia and North and South America.



Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib

Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation. With 2022 sales expectations of $1.9 billion, Zejula is one of the top drug launches of 2017. And with some strong data showing its ability to hold off cancer progression for more than a year in some patients, it could be a quick challenger for market share when it launches, expected in late April.

XELJANZ® receives marketing authorisation in the EU for moderate to severe rheumatoid arthritis

Pfizer Inc. announced that the European Commission (EC) has approved XELJANZ® 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors. The EC approval is based on a submission package that included results from the Phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data.

Innovus Pharma nabs European patent for Sensum+

Innovus Pharmaceuticals received a Notice of Intention to Grant from the European Patent Office for a patent titled “Sensitization composition and method of use” covering its Sensum + product for reduced penile sensitivity. The Notice of Intention to Grant from the EPO adds great value to the CPNP notification to market Sensum+® in Europe. Having a patented product has increased the ability of the company to enter into new commercial partnerships for Sensum+® in Europe. Sensum + is a non-medicated cream used by men to enhance sexual satisfaction.

Alexion brings on former Baxalta chief Hantson to fill vacant CEO spot

Alexion’s CEO search is over. The Connecticut biotech, which bade its skipper farewell late last year, is bringing former Baxalta chief Ludwig Hantson into the fold. Hantson will take the reins from David Brennan, who stepped in as interim CEO after David Hallal made his exit last December. Brennan will remain on Alexion’s board, which expects to appoint him chairman at the company’s mid-May annual meeting, Alexion said.


Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics

Novartis has been mining a pivotal study of Entresto, its heart-failure med, for more insights ever since it was first published in 2014. Now, a new analysis shows that Entresto beat an older med at reducing blood sugar levels in heart failure patients with diabetes. By breaking out and analyzing data on 3,778 diabetic patients who participated in the Paradigm-HF trial, researchers found that those in the Entresto arm saw a 0.26% drop in HbA1c, a commonly used measure of blood sugar levels, compared with 0.16% among those taking enalapril, an older heart failure remedy. And 29% fewer diabetics in the Entresto arm needed to start insulin therapy during the course of the study, compared with those in the enalapril arm.

Diabetes meds from AZ, J&J and Lilly sharply cut death rates in real-world analysis

A massive data analysis showed that SGLT2 diabetes drugs significantly cut heart failure hospitalizations and deaths, results that stand to have a “substantial impact” on prescribing habits, if AstraZeneca’s U.S. president sees his predictions come true. In a real-world study dubbed CVD-Real, researchers sifted records on more than 300,000 patients in six countries to find that SGLT2 meds cut heart failure hospitalization rates by 39% compared with other types of diabetes treatments. The drug class—which includes AZ’s own Farxiga as well as Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance—also reduced deaths from any cause by 51%, according to the study, presented Sunday at the American College of Cardiology conference. The analysis echoes the results of a landmark Jardiance outcomes study, Empa-Reg Outcome, in which patients taking the SGLT2 drug saw a 35% reduction in risk for heart failure hospitalizations.

CAR-T drugs worth up to $649K in childhood leukemia

Health authorities in Britain ran cost-effectiveness numbers on pioneering CAR-T therapies that might be used to treat acute lymphoblastic leukemia in children, and payers may not want to hear the results. A National Institute for Health and Care Excellence mock technology appraisal analysis—highlighted in a Thursday note from analysts at Jefferies—found that a $649,000 price tag on the therapies would be justified for young patients with acute lymphoblastic leukemia (ALL). That doesn’t mean Novartis, Kite and other CAR-T drugmakers will charge that much if and when their treatments get approved in ALL, or that payers would shell out even close to that amount. The Jefferies analysts say the $649,000 figure is likely the “upper bound” on the treatment from Kite, which is working toward a filing in non-Hodgkin lymphoma first. The analysts didn’t discuss the other CAR-T companies in their note.

FDA warns of pancreatitis deaths from treatment with Allergan’s IBS-D med Viberzi

Allergan has been working hard to buoy IBS-D med Viberzi through a series of marketing efforts and tech partnerships. But now, a safety hurdle could get in the way. The FDA has warned that patients without a gallbladder shouldn’t use the med after an agency review found an increased risk for those patients of developing serious pancreatitis that could result in hospitalization or even death. In fact, hospitalizations and deaths from pancreatitis have already been reported in patients without gallbladders who were taking Allergan’s product, the FDA said. Regulators recommended patients in that pool “stop taking Viberzi right away.” It’s a setback for the Dublin drugmaker, which has been pushing hard to expand use of the med since winning a May 2015 approval on the same day as Valeant’s IBS-D contender, Xifaxan.


Pfizer faces first 2017 patent loss as Pristiq generics arrive

Pfizer faces a challenging year on the patent loss front, starting with the generics of its antidepressant Pristiq now hitting the market. Mylan today said it had launched its copycat of desvenlafaxine extended-release tablets, in 50 mg and 100 mg doses. India’s Lupin also has its version on the market and a slew of other generic makers, including Sandoz and Teva’s new Actavis unit, have approvals. Pristiq itself was a drug launched to protect Pfizer sales from the patent loss on a preceding antidepressant, Effexor. Pristiq was first developed by Wyeth before it merged into Pfizer in 2009 to create the drug giant it is today.

Surprised shareholders target Allergan over generics pricing probe

Allergan no longer owns Actavis, having unloaded the generics unit to Teva. That hasn’t kept the drugmaker from facing potential fallout from shareholders who say Allergan’s share price has been stung by questionable pricing practices when it did. Former employee Andrew Ormond launched a class action suit against the drugmaker, arguing its shares were “artificially inflated” between Feb. 25, 2014, and Nov. 2, 2016. Several Allergan press releases and filings from the company praised its own performance during that time, but the lawsuit claims that behind the scenes, things weren’t all that genial. Allergan “and several of its pharmaceutical industry peers colluded to fix generic drug prices in violation of federal antitrust laws,” according to the class action. That put the company “at risk of criminal prosecution and civil and criminal penalties,” factors that investors couldn’t assess, according to the suit.

Chinese drugmakers, PE firms pile into Stada deal action

The race to snatch up generics maker Stada is heating up ever since the Boston private equity outfit Advent International put up the first legally binding bid for the drugmaker, multiple players are reportedly preparing to jump into the fray. CVC Capital Partners, which held deal talks with Stada last year, is ready to come back for another try, and it’s considering joining hands with a Chinese drugmaker to do it. The private equity firm is in early-stage talks with Fosun Pharmaceuticals about a joint bid, which is looking to continue down the global expansion path after acquiring India’s Gland Pharma last year. CVC is also talking with Shanghai Pharmaceuticals Holding about teaming up.

Sun Pharma rallies 7% as USFDA lifts import alert on Mohali unit

Shares of Sun Pharmaceuticals shot up nearly 7 per cent in Tuesday’s trade after said that USFDA on Monday lifted the import alert imposed on the company’s Mohali manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. Following the report, the stock jumped 6.57 per cent to hit a high of Rs 728.45 on BSE. The company’s market capitalisation rose by over Rs 10,000 crore to Rs 1.74 lakh crore. The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction.



NPPA slams pharma giants for overcharging

The price regulator in the pharmaceutical industry, National Pharmaceutical Price Authority (NPPA) has discovered that the leading Pharma companies are overcharging customers for abundantly prevalent drugs in the market. NPPA has alleged that the listed 634 drugs are being sold at prices higher than their ceiling price fixed by the Drug Price Control Order (DPCO). The list includes Pharma giants, Sun Pharmaceuticals, Lupin Pharma, Cipla, Cadila Healthcare and many more. The regulator, NPPA has sent notices to these companies to lower the prices of overcharged drugs to their normal prices as stated under the DPCO. The list of overcharged drugs includes commonly used medicines such as Gelusil, Soframycin and Ring-Guard.

Japan Joins Trump in Drug Price War Crimping Pharma Profits

President Donald Trump has pledged to reverse what he describes as “astronomical” drug prices in the U.S. Thousands of miles away, Japan, long a profit sanctuary for multinational pharmaceutical companies, is taking a similar tack. About $93 billion is spent annually on medications in Japan, and the government plays a key role on prices because it covers about 40 percent of the country’s health spending via its national insurance scheme. In December, officials announced plans to review drug prices more frequently: annually for all therapies and quarterly for the newest and most expensive ones that are used widely. Over recent months, the price of Opdivo was halved in the Asian country following a 32 percent cut in April for Gilead Sciences Inc.’s hepatitis cure Sovaldi. The industry fears that could just be the beginning. With the annual price review in place, the sector’s sales in Japan, the world’s third-largest drug market, are estimated to fall by 30 percent to about $62 billion through 2025.

PCI Pharma Services Announces Significant Expansion in Serialization Technology

Leading outsourcing services provider PCI Pharma Services (PCI) today announced a significant expansion of its market leading Serialization capability. PCI will increase Serialization capacity across its global supply network to support clients in advance of meeting both US DSCSA and EU FMD implementation dates. PCI has been actively serializing commercial products for the past five years, with products destined for North America and Europe, in addition to emerging market geographies such as South Korea, Turkey, Brazil, China and others. In total, PCI supports medicines destined to over 100 global countries. PCI’s announced expansion triples its global Serialization capacity in advance of upcoming DSCSA and FMD requirements.

Merck KGaA opens new Allergopharma plant in Germany

Allergopharma, the allergy meds unit of Merck KGaA, has opened a new biopharmaceutical production plant near Hamburg. The €42 million ($44.4 million), 6,000-square-meter (64,583-square-foot) facility was built at the current Allergopharma complex in Reinbek. It is part of a global expansion, Simon Sturge, CFO of Merck’s healthcare unit, said in a statement. When Allergopharma announced plans for the new facility in 2013, it said about 40 jobs would be added to the site to staff the new, two-story facility, where Allergopharma will make recombinant allergens to treat conditions like hay fever and allergic asthma. About 500 employees work at the site. The company has said this is Allergopharma’s largest investment to date and will help with its expansion into emerging countries like China as well as developed markets.

Mylan and Biocon finally win right to sell Herceptin biosimilar in India

Mylan and Biocon have approvals for their Herceptin biosimilar pending in the U.S. and Europe, but just today won a court ruling that said they may sell their version in India where it was first approved three years ago. The Delhi High Court ruled that the partners have the right to sell their versions of the blockbuster breast cancer drug in India and refer to it as a biosimilar of Herceptin. The two developed the biosimilar together but are each launching their own brands there, CANMAB by Biocon and Hertraz by Mylan. Roche has aggressively fought the introduction of the drug there since 2014, claiming that India’s drug regulator had approved the Mylan and Biocon drug before it had adopted guidelines for how biosimilars would be approved. The Swiss drugmaker claimed the two companies relied on Roche data, rather than their own, to develop their product and that there was no guarantee of biosimilarity and so shouldn’t be sold as one.


Prosecutors rope Pfizer into fast-growing copay assistance probe

After first focusing on biotech and speciality pharma, the feds have made their way to Big Pharma, with the New York drug giant joining a group that includes Gilead Sciences, Biogen, Valeant Pharmaceuticals and others about ties to copay assistance programs. Such patient assistance programs have come under fire lately, with critics arguing pharma companies use them to boost sales. Governmental regulations prohibit drugmakers from linking their charitable contributions to their own meds, and drug companies aren’t allowed to offer direct co-pay assistance to patients covered by Medicare or Medicaid. Before Pfizer, Regeneron was the latest to disclose a subpoena in the government’s growing probe.

Pharma groups to FDA: Stop that new off-label rule in its tracks

Cheered by victories in off-label marketing lawsuits, pharma companies were expecting some loosening of the regulatory shackles when the FDA rolled out a new rule on the subject. But that rule, published in the Federal Register last month, sent drugmakers into a minor tizzy—and industry groups are demanding that the FDA set its new off-label regime aside. In a citizen petition filed earlier this month, and recently posted to the agency’s website, the industry groups PhRMA and BIO and the Medical Information Working Group called on the FDA to stay the new rule and instead use a standard proposed in September 2015.

Regeneron simulates retinal disease with virtual and augmented reality app

Together with Intouch Solutions, Regeneron Pharmaceuticals has created a virtual and augmented reality app called “In My Eyes” that allows viewers to experience the blurriness, wavy lines or black patches caused by different types of retinal disease. The app can be used with or without VR goggles and works in two modes. In story mode, viewers look around a doctor’s office in full 360 degrees and see three patients waiting. Choosing any patient will open up that person’s story along with a video from their life, like a birthday party or picnic, shown through their specific retinal eye disease view. The three diseases featured are neovascular age-related macular degeneration or wet AMD; diabetic macular edema or DME; and macular edema following retinal vein occlusion, or MEfRVO. The second view is live mode, which engages the phone’s camera to allow viewers to see whatever is in their field of vision through the three different retinal conditions.

Otsuka and Lundbeck revive Rexulti mask campaign as U.S. uptake soars

The Pfizer fill-finish plant whose manufacturing problems have gut-punched the expected approval of a generic of Teva’s long-acting Copaxone is a former Hospira plant with a history of issues. Execs at Momenta, which is developing the generic drug with Sandoz, said this week that they think an approval is still possible this year, but at least one researcher that has taken a deep dive into the Form 483 issued to the plant says he will be surprised if the issues can be resolved before late next year. The FDA issued a warning letter last week to the McPherson, Kansas, plant which is handling the fill and finish of Glatopa for Momenta and Sandoz. The facility already produces their 20-mg version, which was approved in 2015, and which Pfizer says is unaffected by the warning letter. The more valuable long-lasting 40-mg dose was expected to be approved this quarter.

Former Valeant, Philidor execs plead not guilty to multimillion-dollar fraud and kickback charges

The former Valeant and Philidor execs accused of engineering a multimillion-dollar fraud and kickback scheme deny the charges. Former Valeant senior director Gary Tanner and former CEO of now-dead specialty pharmacy Philidor, Andrew Davenport, pleaded not guilty to charges from federal prosecutors. The pair was indicted on four counts, including conspiracy to commit wire fraud and conspiracy to commit money laundering. According to the FBI special agent handling the investigation, Tanner received $10 million in kickbacks issued by Davenport that were “laundered through a series of shell companies and transactions designed to conceal the illicit payments,” DOJ documents said.



USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violations

US health regulator USFDA has red-flagged significant deviations from manufacturing norms at the Bengaluru-based API facility of Resonance Laboratories, including failure to have adequate cleaning procedures to prevent contamination of products. Summarizing the deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), USFDA said it had inspected the drug manufacturing facility on May 2-6, 2016. Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Resonance Laboratories at the Bengaluru plant into the United States, it added.

Vitamin B3 prevents glaucoma according to researchers in US.

Researchers from The Jackson Laboratory (JAX), US, have found that vitamin B3, when added to drinking water, is effective at preventing glaucoma. The research was carried out by a team led by professor and Howard Hughes medical investigator Simon John. Glaucoma is one of the most common neurodegenerative diseases and affects an estimated 80 million people worldwide. By administering the vitamin, the majority of age-related molecular changes were eliminated, providing a protection against glaucoma. New interventions can be developed to protect from common age-related disease processes in many people by understanding general age-related mechanism, the research noted.

Zydus Cadila receives USFDA nod to market fluconazole tablets

Zydus Cadila has received the final approval from the United States Food and Drug Administration to market fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg and Clobetasol Propionate spray, 0.05 per cent. Fluconazole tablet, which is used to treat fungal infections, will be produced at the group’s formulation manufacturing facility at Baddi. The group now has more than 105 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04 fiscal.

U.S. experts soften on DNA editing of human eggs, sperm, embryos

The report from the National Academy of Sciences (NAS) and the National Academy of Medicine said scientific advances make gene editing in human reproductive cells “a realistic possibility that deserves serious consideration.” The statement signals a softening in approach over the use of the technology known as CRISPR-Cas9 that has opened up new frontiers in genetic medicine because of its ability to modify genes quickly and efficiently. In December 2015, scientists and ethicists at an international meeting held at the NAS in Washington said it would be “irresponsible” to use gene editing technology in human embryos for therapeutic purposes, such as to correct genetic diseases, until safety and efficacy issues are resolved. Though the technology is still not ready, the latest NAS report says clinical trials for genome editing of the human germline could be permitted, “but only for serious conditions under stringent oversight.”