Notizia

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.”

Notizia

In letter to Allergan, SEC says it will scrutinize industry’s use of non-GAAP accounting

When the SEC criticized Valeant Pharmaceuticals over its use of non-GAAP reporting, it seemed like a regulator barking at a company known for pushing the limits. But now the agency has fired a warning shot across the bow of the industry, saying in a letter to Allergan that it intends to examine how the industry is potentially exploiting the practice. In its Jan. 11 letter to Allergan CFO, the SEC admonished the company for using non-GAAP in reporting its earnings per share. While other companies may do the same thing, and the agency said it didn’t agree with its use that way.

Acacia Pharma’s Baremsis meets primary endpoint in pivotal phase 3 study

Acacia Pharma Group Ltd., the supportive care company developing products for US and international markets, has announced positive results from its fourth and final pivotal phase 3 study investigating Baremsis (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior antiemetic prophylaxis.  Acacia Pharma has now completed four pivotal phase 3 studies of Baremsis successfully, all meeting their primary endpoint, and these will form the basis of the efficacy and safety package which the Company aims to submit to the US FDA as part of its New Drug Application (NDA) in 1H 2017.

Phase 3 test is on the way for Axovant’s dementia drug

Positive results in a first crop of patients treated with its dementia drug have encouraged Axovant to start preparing for a phase 3 study. So far 11 patients with Lewy body dementia (LBD) have been treated with nelotanserin, which is being developed to tackle the visual hallucinations and sleep disturbances that can afflict people with these diseases. The results have outpaced expectations, with nelotanserin achieving a significant improvement in extrapyramidal symptoms—Parkinson’s disease-like effects caused by the nerve degeneration in LBD—as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). Final data are due mid-year, with the phase 3 trial due to start in the second half of the year.

Novartis expands Vivinda TV, offering docs digital access to medical conferences

Vivinda TV, a burgeoning virtual conference platform created to deliver on-demand medical content, most recently aired the full unedited content from the European Cancer Congress held in Amsterdam last month. And the platform has worked so well that Novartis is ramping it up. In June, for the American Society of Clinical Oncology conference, Vivinda TV drew 4,600 registrations from virtual delegates in 103 countries, and for the European School for Advanced Studies in Ophthalmology conference, Vivinda TV drew 1,800 virtual delegates—compared with the 500 to 600 that attend in person. Currently, the platform can be accessed by healthcare providers in any country except Canada, Japan, Norway, Sweden and the U.S.

Aurobindo responds to White House urging, plans second U.S. plant

Aurobindo Pharma, which just started on its first U.S. plant in August, said today it will build a second sterile injectables plant at its site in New Jersey. Hyderabad-based Aurobindo, which derives about half of its finished drug sales from the U.S., still produces most of those in India, where it has half a dozen plants. Today, the company reported third-quarter earnings of 3.9 billion INR ($58.4 million), up 11.5%. It said that U.S. sales of both oral and injected drugs were up 12% for the quarter but that pricing pressure on generic meds in the U.S. had dampened its earnings.

Notizia

FDA approves Bristol-Myers Squibb’s Opdivo injection to treat mUC

Bristol-Myers Squibb’s Opdivo injection (nivolumab) has been approved by U.S. FDA for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This indication is approved based on tumour response rate and duration of response and its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. The company received the application priority review and breakthrough therapy designation for Opdivo from the FDA to treat patients with locally advanced or mUC.

Sun Pharma Recalls 2.7 Lakh Bottles of Antidepressant

Sun Pharma is recalling over 2.7 lakh bottles of bupropion hydrochloride extended-release tablets used for treatment of major depressive disorders in the US due to failed dissolution specifications. The recall is being initiated by Sun Pharmaceutical Industries Inc. for 2,71,212 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strengths of 150 mg and 200 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

Mezzion Pharma has filed a suit against Dr Reddy’s Laboratories in the US

Mezzion has filed a suit for damages against Dr. Reddy’s in New Jersey State Court alleging that Dr. Reddy’s committed fraud relating to the latter hiding significant deficiencies in its Food and Drug Administration (FDA) cGMP practices, and misrepresenting its compliance to Mezzion. According to Dr. Reddy’s, they have not been served with any legal papers or legal process in the matter referred to in Mezzion’s press release. In 2015, Dr. Reddy’s had received a warning letter from the US Food and Drug Administration (USFDA) for two of its active pharma ingredients (API) manufacturing plants and a formulation facility located in Andhra Pradesh and Telangana.

Sanofi’s antibody to treat patients with rheumatoid arthritis gets Approved

Sanofi has received approval from Health Canada for Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, to treat adult patients with moderately to severely active rheumatoid arthritis (RA). The approval was based on data from about 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. The fully human monoclonal antibody Kevzara binds specifically to soluble and membrane-bound IL-6 receptors, and has been shown to inhibit IL-6-mediated signalling through these receptors.

Notizia

AstraZeneca announces availability of Saxa / Dapa FDC in UK

UK-based AstraZeneca has announced the availability of Qtern for adult patients with type 2 diabetes in the country. Quern is a fixed dose combination of saxagliptin and dapagliflozin. The tablet received marketing authorization from the European Commission on 19 July last year and is indicated in adults aged 18 and older with type 2 diabetes in order to improve glycemic control. The European Commission approved the tablet based on data from three Phase III randomised.

Saxa / dapa FDC can be used in patients with mild renal impairment and should be avoided in patients with moderate-to-severe renal impairment.

Trivitron launches its digital radiography system Ultisys at Arab Health 2017

Trivitron Healthcare’s radiology division Kiran Medical Systems has now introduced its innovation driven Ultisys range of radiography products during the Arab Health Convention in Dubai. Ultisys offers an affordable yet versatile platform for a wide range of clinical applications involving general radiography.

Kiran’s portfolio of radiology products includes the Infinity and Elite series surgical C-Arm systems available in 3.5kW and 5.0kW power output and the option of 1Kx1K digital imaging chain with advanced image processing capabilities.

BrainStorm Cell Therapeutics validates NurOwn Cryopreservation

Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that it has validated its cryopreservation process for NurOwn in preparation for the upcoming phase 3 clinical study in amyotrophic lateral sclerosis (ALS).

The validation involved a comparison of NurOwn (MSC-NTF cells) derived from fresh mesenchyme stem cells (MSC) to those derived from cryopreserved MSC.  Company scientists were successful in showing that the MSC can be stored in the vapour phase of liquid nitrogen for prolonged periods of time while maintaining their characteristics.

NEI scientists identify stem cell secretions may protect against glaucoma

A new study in rats shows that stem cell secretions, called exosomes, appear to protect cells in the retina, the light-sensitive tissue in the back of the eye. The findings, published in Stem Cells Translational Medicine, point to potential therapies for glaucoma, a leading cause of blindness in the United States. The study was conducted by researchers at the National Eye Institute (NEI), part of the National Institutes of Health (NIH).

Notizia

U.K. weighs drug rationing as NHS England’s budget tightens: report

Patients in the U.K. face yet another barrier to access as a tough budget situation has forced the country’s healthcare system to consider rationing costly drugs. Among them are medicines from Johnson & Johnson, Merck and Roche. Beginning in April, cancer patients and others could have to line up for medicines that cost NHS England more than £20 million per year, The Times reported. That’s even after those meds have been deemed cost-effective by the National Institute for Health and Care Excellence (NICE). The move comes at a troublesome time at NHS, as its chief executive, Simon Stevens, said publicly this month that Prime Minister Theresa May was “stretching the truth” about the agency’s budget. He said NHS received “less than we asked for” from the British government.

Applying Digital Technologies to Profit from Change in the Pharma Industry

Pharmaceutical companies are increasingly challenged to keep pace with the evolving demands of patients, physicians and payers. Patients are increasingly seeking higher levels of involvement and understanding of their own treatment plans. In fact, a recent survey found that more than 85% of patients are confident in their ability to take responsibility for their health and knew where to access online resources to do so. Much of this information is sought after via mobile devices: over 60% of smartphone users use their mobile devices to search for information regarding a health condition. Furthermore, patients are increasingly favoring third party sites where they can obtain syndicated information on health conditions and related treatments.

Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds

There’s no denying that financial incentives for orphan drug development saved hundreds of thousands of lives. But they’ve also helped mass-market drug makers rack up millions in incentives, tax breaks and patent-protected profit. According to a report, About one-third of the orphan drug approvals since the program began have been for repurposed, large-market products or drugs with multiple orphan green lights. Best-sellers such as Crestor from AstraZeneca, Abilify from Otsuka, Herceptin from Roche and Humira from AbbVie fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations. Others, such as Allergan blockbuster Botox, started out as small-market meds and proceeded to collect multiple orphan approvals.

FDA slaps Florida blow-seal-fill facility with warning letter

The FDA has come down on an aseptic blow-fill-seal pharma manufacturing operating in Florida that the agency says has widespread issues with microbiological contamination. The FDA posted a warning letter that was issued last month to Horizon Pharmaceuticals following an inspection that dates back to the fall of 2015. The FDA said that when it inspected the company’s facility in Riviera Beach, Florida, it “found multiple deficient practices at (the) facility that pose a significant microbiological contamination risk.” Among those was its cleaning and disinfection program, which it said didn’t use a sporicidal agent. The inspectors discovered the facility had shipped three lots of an ophthalmic drug even though some bottles which were tested were contaminated with Bacillus mycoides, which is a spore-forming microbe.

Notizia

US FDA accepts Mylan’s BLA for proposed trastuzumab product

Biocon and Mylan have announced acceptance of the latter’s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. Mylan’s MYL-1401O is indicated to treat certain HER2-positive breast cancers.Nearly two million women across the globe are diagnosed with breast cancer every year. Mylan has exclusive commercialisation rights for this product in the US, Canada, Japan, Australia, New Zealand and the European Union and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan in the remaining parts of the world.

Merck’s Keytruda takes combo lead with surprise FDA filing

Merck & Co.’s immunotherapy drug Keytruda is yet another step closer to eclipsing its competitors in lung cancer. In an out-of-the-blue announcement, the U.S.-based drugmaker said the FDA had accepted its application for a new Keytruda-plus-chemotherapy combo use that could expand its market considerably, and was granted priority review to boot. Merck had previously unveiled some impressive study data on the chemo combo approach, and Merck’s application is based on data from the Keynote-021 trial, and, if approved, would be Keytruda’s first in combination with another drug.

M Pharmaceutical to develop new topical drug product for FSD

Canadian-headquartered M Pharmaceutical has announced its plan to continue advancing the development of a topical drug product as part of its planned acquisition of 40 J’s. The drug will be used for the treatment of female sexual dysfunction (FSD). According to the company’s CEO, this topical drug product would focus on women with orgasm and arousal difficulties. The company’s proposed treatment is topical, local and non-systemic, while being non-hormonal and is not a central nervous system drug.

Merck KGaA to Deploy Palantir Data Analytics

Merck KGaA has partnered with Palantir Technologies, a developer of data integration and analysis software, headquartered in Palo Alto, CA. The partnership will leverage Palantir’s data analytics capabilities to help Merck KGaA rapidly develop and commercialize new products and improve patient outcomes.   Initially, Merck KGaA will apply the technology to cancer treatment and patient services and then across all three of its business sectors: Healthcare, Life Science and Performance Materials. The partnership aims to increase precision of the drug development process by developing a collaborative data and analytics platform so that researchers can analyze real-world and bioinformatics data to understand the patients who may benefit most.

 

Notizia

Greek prosecutors raid Novartis offices, disclose wide-ranging probe into bribery allegations

Greek officials announced that they are investigating Novartis for bribery in the wake of local media reports raising questions about the company. It is the fourth set of bribery allegations against the Swiss drugmaker to go public in the past year. Greek authorities have interviewed scores of sources and raided Novartis offices in Greece, according to multiple local news outlets. Justice Minister Stavros Kontonis ordered the inquiry after “denunciations concerning bribes paid to functionaries by Novartis” appeared in the press.

Sanofi, Regeneron one step closer to owing PCSK9 royalties as judge upholds Amgen patent ruling

Amgen has been in a tight race with Sanofi and Regeneron to win market acceptance for a new class of drugs that fight ultra-high cholesterol by inhibiting an enzyme called PCSK9—a fight that includes a patent-infringement claim. On Tuesday, Amgen kept the upper hand in that patent case, which could put the company in line to collect royalties from Sanofi’s and Regeneron’s treatment.

Pharma’s deal prices have quadrupled in the last two years

Drugmakers shelled out twice as much for acquisitions in 2016 as they did in 2015—and it wasn’t because those buys were twice as valuable. Cheap credit and an industrywide scramble to boost pipelines have together inflated the prices pharma’s paying, and that trend isn’t necessarily over. The median value of a pickup in 2016 was 39 times the takeover target’s revenue, compared with 19 times revenue in 2015 and eight times in 2014.

J&J and Actelion’s potential deal fix? $260 per share for marketed meds, spinoff for pipeline

Would-be deal partners Johnson & Johnson and Actelion are onto their second round of talks, and this time, Actelion may just get the transaction it’s been hoping for. The pair is hammering out a pact that would split Actelion’s commercialized meds from its R&D assets. Actelion’s pipeline prospects would spin off into a new publicly traded company, while J&J would snap up the marketed meds with a cash offer in the neighborhood of $260 per share—slightly more than the figure the New Jersey Company offered up before throwing in the towel last month.

Notizia

Sanofi sues Novo over ‘misleading’ Tresiba marketing materials

Sanofi has sued Novo over the Danish drugmaker’s marketing materials for Tresiba, alleging that they falsely claimed Sanofi’s competing products—blockbuster Lantus and follow-up Toujeo—won’t be available to many U.S. patients down the line. The pharma giant is seeking an order to force Novo to pay unspecified money damages and pull the materials in question. According to Sanofi’s complaint, filed in U.S. District Court for the District of New Jersey, the materials urged doctors and patients to make the change in treatment because Sanofi’s meds would supposedly be “blocked” in January.

Acquisitive Allergan gets top-line help, cost-savings potential with $2.9B LifeCell buy

The Dublin drug maker has inked a pact to pick up regenerative medicine player LifeCell for $2.9 billion in cash. LifeCell racked up about $450 million in 2016 revenue that’ll boost Allergan’s own top line going forward, and it’s expanding at a mid-single digit rate. The addition of LifeCell’s product line—which includes human allograft tissue matrix AlloDerm, fat-grafting device Revolve and procine-based tissue matrix Strattice—will help Allergan create a world-class aesthetic and regenerative medicine business providing significant opportunity to enhance the overall product offering for plastic and general surgery customers globally.

Actelion snubs Sanofi and restarts talks with J&J

Swiss drugmaker Actelion is back at the negotiating table with Johnson & Johnson, appearing to have given Sanofi the cold shoulder just as the French drugmaker was thought to have figured out how to bring the biotech to ground. While investors were hoping for culmination of a deal before Christmas, a source pointed that it is “neither impossible nor unusual” to see big deals finally tied up around Christmas and New Year’s Eve.

Impax CEO Wilkinson out as company searches for new leadership

Under a “mutual agreement” with the board, Impax CEO Fred Wilkinson is departing the company, to be replaced by board member J. Kevin Buchi on an interim basis. The move comes as the company’s stock has steadily drifted down in recent years and now is trading at its lowest point since 2010. Wilkinson will depart after more than two years at the California-based generic and specialty Pharma Company. Buchi, who only joined the board last month, will serve until Impax can find a permanent leader. Buchi currently serves as CEO at TetraLogic Pharmaceuticals, where he’s expected to step down by the end of the year.

Notizia

For Inflectra launch, Pfizer uses ‘hybrid model’ to home in on HCPs

Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson’s Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—while required to be “highly similar”—are technically different and come with different datasets and proof points. So, Pfizer went to work to create a new “hybrid model” to bring biosimilars to market. Through this model, each biosimilar brand launch will be customized, each will also leverage the scale of the model platform.

US FDA approves Rubraca to treat advanced ovarian cancer

The US Food and Drug Administration (FDA) has granted approval to Rubraca (rucaparib) for the treatment of advanced ovarian cancer in women. The poly ADP-ribose polymerase (PARP) inhibitor Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumours have BRCA gene mutation as identified by a companion diagnostic test approved by the FDA. Involved with repairing damaged DNA, BRCA genes normally work to prevent tumour development. Mutations of these genes are expected to lead to certain cancers, including ovarian.Rubraca blocks an enzyme involved in repairing damaged DNA.

EMA approves MSD’s PD-1 therapy Keytruda to treat patients with NSCLC

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of MSD’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC). Keytruda is an anti-programmed death-1 (PD-1) therapy that blocks the biological pathways cancers use to disguise themselves from the immune system. The drug has been recommended for patients with NSCLC whose tumours have high PD-L1 expression with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.

Mylan launches authorized generic version of EpiPen

Mylan has launched the authorized generic version of EpiPen (epinephrine injection, USP) auto-injector, after the recent price hike criticism. The self-injectable device (auto-injector) contains epinephrine, the first-line treatment for life-threatening allergic reactions or anaphylaxis. Expected to reach pharmacies from next week, the authorized generic has the same drug formulation and device functionality as EpiPen auto-injector that is administered in the same way. The authorized generic for EpiPen is available in strengths of 0.15 mg and 0.3 mg.

Notizia

CDC study reveals Zika virus replicates in foetal brain and placentas

Study conducted by the US Centers for Disease Control and Prevention (CDC) has revealed that the Zika virus replicates in the brain tissues of infants with microcephaly and persists in foetal brains and placentas of women who suffered pregnancy losses. The study noted that the virus can make several copies of itself in the brains and placentas, which may help explain how it causes birth defects and pregnancy losses. The study’s main focus is how the virus can cross the placenta and infect the foetus’s brain. As part of the study, tissues from 52 patients with suspected Zika virus infection, including brain tissues from eight infants with microcephaly, were tested by the researchers. It was found that Zika infects and proliferates in Hofbauer cells in the placenta, which can move freely throughout and help transfer the virus to the foetus’s brain.

Sanofi’s Jevtana drug receives SMC approval to treat prostate cancer

The Scottish Medicines Consortium (SMC) has accepted Sanofi Genzyme’s Jevtana (cabazitaxel) for routine use in NHS Scotland to treat metastatic hormone-refractory prostate cancer (mHRPC). Jevtana (cabazitaxel) is a chemotherapy option available on the NHS for advanced prostate cancer that is not responsive to hormone therapies, following initial chemotherapy (docetaxel). The decision reduces potential disparities in care across the UK for this vulnerable group of patients. Initially, the SMC rejected Sanofi Genzyme’s updated application in June this year. Patients treated with the plant-based chemotherapy Jevtana can experience side effects such as anaemia, infections / sepsis, low blood counts and diarrhoea.

Herantis Pharma secures EU Horizon 2020 programme grant for Parkinson study

Herantis Pharma has secured a grant from the European Union (EU) for the Phase I-II clinical study with its drug candidate cerebral dopamine neurotrophic factor (CDNF) to treat Parkinson’s disease (PD), using a new drug administration device of Renishaw. With the €6m grant from the EU Horizon 2020 programme (TreatER), Herantis also plans to carry out scientific research at the University of Helsinki and the University of Oxford. A consortium of 11 members, including Herantis as the formal sponsor of the clinical study and the owner of CNDF patents, and the University of Helsinki will execute the TreatER project.

Immuno-oncology isn’t cost-effective for global cancer treatment, according to GSK Chief

GlaxoSmithKline CEO Andrew Witty swapped off his oncology assets to Novartis, building his company’s position in vaccines and consumer healthcare instead. After taking flak from prominent investors, Witty continues to defend the logic—to make the case that high-priced treatments don’t make business sense in the long run. At the opening of GSK’s Rockville, Maryland, vaccine research site, Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.” He said the number of patients treated by the last 20 top-selling pharma products has dropped “catastrophically” in recent decades.