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Mylan has reached a $465-million settlement with the US government to resolve claims relating to the classification of the company’s EpiPen Auto-Injector and EpiPen Jr Auto-Injector, auto-injector-based epinephrine products for treating adverse allergic reactions, for purposes of the Medicaid Drug Rebate Program. In August 2016, Mylan came under US government attention regarding the pricing of the EpiPen Auto-Injector, and in October 2016, the company agreed to the $465-million settlement, which is now finalized. The question in the underlying matter was whether the EpiPen products were properly classified with the Centers for Medicare and Medicaid Services ...
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Valeant Pharmaceuticals International, a specialty pharmaceutical company, reports that the US Food and Drug Administration (FDA) intends to issue a Voluntary Action Indicated (VAI) inspection classification for the company's Bausch + Lomb manufacturing facility in Tampa, Florida as part of a forthcoming Establishment Inspection Record for the facility. The company says with confirmation of this classification, manufacturing uncertainties related to current and upcoming regulatory submissions will be eliminated for products manufactured at the Tampa facility. A VAI inspection classification occurs when objectionable concerns were observed by the FDA inspectors ...
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Biocon, a Bangalore, India-based pharmaceutical manufacturer, plans to resubmit its marketing authorization application (MAA) to the European Medicines Agency (EMA) for biosimilar candidates to Roche’s Herceptin (trastuzumab), a cancer drug, and Amgen's Neulasta (pegfilgrastim), a drug to stimulate white-blood cell production after chemotherapy, following an inspection of manufacturing facilities making these products. The products are top-selling products for the innovator companies. Roche's Herceptin had 2016 sales of CHF 6.78 billion ($7.04 billion), and Amgen's Neulasta had 2016 sales of $4.65 billion.  In July 2017, Biocon was cited by French regulatory ...
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GlaxoSmithKline (GSK) has opened a new £44-million ($57 million) manufacturing plant to support vaccine production in Montrose, Scotland. The facility will manufacture sterile aluminum salts for vaccines for tetanus, pneumonia, diphtheria, and whooping cough. The announcement was from the Scottish government. The new facility is expected to be fully operational in 2019 and includes a microbiology laboratory. The salts were previously sourced outside Scotland, and GSK has chosen the Montrose site to produce these salts, which will supply GSK’s vaccines sites in France, Belgium, and Singapore. “With this new facility, we’ll be making a key ingredient for ...
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Orchard Therapeutics, a London-headquartered biotechnology company, has appointed Mark Rothera as president and chief executive officer. Rothera has 28 years of experience in the biopharmaceutical industry. Rothera previously served as chief commercial officer of PTC Therapeutics, a South Plainfield, New Jersey-based biopharmaceutical company. Prior to joining PTC, he served as global president of Aegerion Pharmaceuticals, a Tottori, Japan-based biopharmaceutical company, and as vice president and general manager of commercial operations at Shire’s Human Genetic Therapies division for Europe, the Middle East, and Africa. Source: Orchard Therapeutic
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The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports, to recommend the types of manufacturing changes for approved biologics license applications (BLAs) that need to be documented in an annual report. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) post-approval manufacturing changes that the FDA generally considers to have a minimal potential to have an adverse effect on product quality. Under FDA regulations, post-approval changes in the product, production process, quality controls, equipment, facilities, ...
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Avista Pharma Solutions, a Durham, North Carolina-headquartered contract testing, development, and manufacturing organization, has completed the expansion and upgrade of its analytical laboratories at its Durham facility. Comprised of two laboratories, the analytical research and development and quality control labs have now doubled in size with expanded service offerings.  Avista’s offering now includes: (1) chromatographic method development for assay and related substances, potential genotoxic impurities, organic volatile impurities and residual solvents; (2) spectral identification using upgraded fourier transform infrared spectroscopy, nuclear magnetic ...
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Corning, a material-sciences company, has formed two separate supply pacts for its new glass packaging product, Corning Valor Glass, an alkali aluminosilicate-based parenteral drug packaging product for injectable drugs. The pacts follow a July 2017 announcement by Corning involving a $4-billion investment, including manufacturing, in pharmaceutical packaging with the introduction of Valor Glass. Under the first agreement, Corning formed an collaboration with Stevanato Group, a Dese, Italy-based parenteral glass packager, for supplying Corning Valor Glass. Corning and Stevanato Group have been working together since 2011 for pharmaceutical containers. The ...
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MilliporeSigma, part of Merck KGaA, has entered into a pact with the Baylor College of Medicine and its vaccine product development partner, Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD), to advance vaccines for emerging infections. MilliporeSigma’s experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor to optimize the vaccine manufacturing process to increase vaccine stability and yield. Initially, these activities are targeting schistosomiasis, a parasitic disease that affects people in tropical and subtropical regions. The collaboration includes training and exchange ...
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Gilead Sciences and Shire. Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, August 9, 2017 to Tuesday, August 15, 2017. FDA Grants Priority Review to Gilead’s HIV Drug Combo The US Food and Drug Administration (FDA) has granted priority review for Gilead Science’s new drug application (NDA) for a combination drug for treating HIV-1 infection. The drug is an investigational, fixed-dose combination of bictegravir (50 mg) (BIC), an investigational integrase strand ...
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Mylan. Editor's Note: This article was updated on a continuous basis for news announced from Wednesday August 9, 2017 to Tuesday August 15, 2017. Mylan Launches Three Antiretroviral Drugs in Canada Mylan Pharmaceuticals, a subsidiary of Mylan, has launched three generic products indicated for treating HIV-I infection. Mylan received final approval from Health Canada, the national pharmaceutical regulatory authority in Canada. One of the products is emtricitabine/tenofovir disoproxil fumarate 200 mg/300 mg, a generic alternative to Gilead Sciences’ ...
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Peregrine Pharmaceuticals, a Tustin, California-headquartered biopharmaceutical company, has reduced its overall workforce by 60 employees, or 20% of its workforce, as part of a series of planned strategic actions. The company expects the workforce reductions to result in a net cost savings of between $3.7 million and $4.3 million in fiscal year 2018 and more than $7 million in reduced annualized operating expenses beginning in fiscal year 2019. As part of the cost-saving initiatives, the company reduced Peregrine's research and development (R&D) personnel by 50% to 11 employees. The remaining staff will support potential strategic alternatives for its ...
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Sutro Biopharma, a San Francisco, California-headquartered biopharmaceutical company, has revised its previous collaboration with Celgene for antibody drug conjugates (ADCs). Celgene has also terminated an earlier option to acquire Sutro. Specifically, Sutro has refocused its 2014 immuno-oncology collaboration with Celgene on four programs that are advancing through preclinical development, including an ADC program targeting the B-cell maturation antigen (BCMA). Sutro may also produce both GLP (good laboratory practice) and cGMP (current good manufacturing practice) material as the BCMA ADC program progresses. These programs are in addition to Sutro’s ...
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Pfizer plans to invest $100 million to expand a gene-therapy manufacturing plant in Sanford, North Carolina. Pfizer had acquired the facility as part of its acquisition of Bamboo Therapeutics, a Chapel Hill, North Carolina-headquartered biotechnology company, in 2016. The expansion in Sanford will focus on gene therapy, a technology focused on specialized, one-time treatments that address the root cause of diseases caused by genetic mutation. The technology involves introducing genetic material into the body to deliver a correct copy of a gene to a patient’s cells to compensate for a defective or missing gene. The acquisition of Bamboo expanded Pfizer’s ...
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Sanofi has filed a patent-infringement lawsuit for two patents against Merck & Co. in a federal district court regarding Sanofi’s top-selling product, Lantus (insulin glargine), which had 2016 sales of EUR 5.7 billion ($6.7 billion). The suit was triggered by a notification received by Sanofi in late June 2017 in which Merck stated that it had filed a new drug application ([505(b)(2) NDA]) with the US Food and Drug Administration (FDA) for an insulin glargine vial drug product. A 505 (b)(2) NDA is a pathway created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. It applies to various ...
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Bayer Healthcare Pharmaceuticals has issued a voluntary Class II recall of more than one million (1,067,520) 12-count cartons of its over-the-counter product, Alka-Seltzer Original (325-mg aspirin, 1916-mg analgesic, sodium bicarbonate/antacid, 1000-mg anhydrous citric acid) effervescent tablets. The recall was due to defective containers based on a confirmed customer compliant of small holes or cracks in the foil of blister packs. A Class II recall is a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences ...
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Amgen lost a round in litigation in seeking to defend its product, Epogen (epoetin alfa), a drug to treat anemia associated with chronic renal failure and cancer chemotherapy, from biosimilar competition. A federal appeals court ruled that it does not have jurisdiction over a federal district court ruling that denied Amgen’s request for more information about a proposed biosimilar of epoetin alfa from Hospira, a subsidiary of Pfizer. Epogen is a top-selling product for Amgen with 2016 sales of $1.28 billion.  The dispute involved disclosure requirements and related information-exchange requirements under the Biologics Price Competition and Innovation Act ...
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German pharmaceutical regulators have issued a statement of noncompliance of good manufacturing practice (GMP) to Dr. Reddy’s Laboratories for its dosage-form manufacturing plant (Unit 2) in Bachupally, Hyderabad, India. The company was cited for non-compliance in manufacturing for the following areas: non-sterile products (processing operations for several dosage forms [hard-shell capsules, tablets, and other coated tablets and granules]); primary packaging (hard-shell capsules, soft-shell capsules, tablets, and other non-sterile medicinal products [coated tablets and granules]); secondary packaging; and quality-control testing (microbiological/non-sterility ...
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SK Capital, a New York, New York-based private investment firm focused on the specialty materials, chemicals and pharmaceuticals sectors, has agreed to acquire Perrigo API, Perrigo’s active pharmaceutical ingredients (API) business in Israel, for $110 million. As part of the transaction, the parties have agreed to enter into a long-term supply agreement for Perrigo API to supply multiple existing commercial and pipeline APIs to Perrigo. The transaction is expected to close during the fourth quarter of 2017, before which a new trade name will be selected and announced. Perrigo API is a developer and manufacturer of generic APIs and finished dose forms with ...
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The US Senate has voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic drugs, and biosimilars. In a separate move, the US Food and Drug Administration (FDA) has  released draft goals and procedures for a potential user-fee program for nonprescription or over-the-counter (OTC) drugs.  The Senate voted on August 3, 2017 to pass the The FDA Reauthorization Act, which follows the July 2017 passage of the bill from the US House of Representatives. The bill reauthorizes user-fee programs for the five-year period beginning October 1, 2017. The bill now goes to President Trump for consideration for signing ...
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