News & Insights

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Emergent BioSolutions Inc., a global life-sciences company with contract biomanufacturing services, opened its newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore, Maryland. The facility is one of three centers designated by the US Department of Health and Human Services to provide advanced development and manufacturing of medical countermeasures to support the US. government’s national security and public health emergency needs. Emergent has doubled the Bayview facility’s footprint to 112,000 square feet with investments to the original 56,000-square-foot facility purchased by the company ...
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Aduro Biotech, a biopharmaceutical company witht immunotherapy technologies, has expanded its clinical collaboration with Merck & Co. Inc, to include an additional Phase II clinical trial. Keytruda is one of Merck's top-selling drugs with 2016 global sales of $1.4 billion. The companies will investigate the combination of CRS-207, Aduro’s LADD-(live, attenuated double-deleted) based immunotherapy, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease progressed following prior treatment. Earlier this year, Aduro announced a Phase II clinical collaboration with Merck, ...
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AstraZeneca has entered into an agreement with Recordati S.p.A, an Italian pharmaceutical company, for the commercial rights to Seloken/Seloken ZOK (metoprolol tartrate and metoprolol succinate, respectively) and associated Logimax fixed-dose combination (metoprolol succinate and felodipine) treatments in Europe. Metoprolol succinate is a beta-blocker for the control of hypertension, angina, and heart failure. Recordati will pay AstraZeneca $300 million upon completion of the agreement. AstraZeneca will also receive sales-related income through tiered royalties, initially at a double-digit percentage of sales. AstraZeneca will manufacture and supply the medicines ...
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A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news, with news from Sanofi.b> Editor’s note: This article was updated on a continuous basis from news announced from Wednesday May 17 to Tuesday May 23, 2017. Sanofi Receives FDA OK for Rheumatoid Arthritis Drug Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have received US Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for treating adults with moderately to severely active rheumatoid arthritis (RA). The drug is specifically approved for those patients who have had an inadequate ...
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Novartis plans to add 350 new positions for biological development and manufacturing in Switzerland while cutting approximately 500 positions in traditional production, coordination, and development areas in Switzerland over the next 18 months. The move is part of the company’s ongoing transformation into an integrated business model. The announcement was made as part of an interview with Matthias Leuenberger, Novartis Delegate for Switzerland, and posted on Novartis’ Swiss website. The restructuring will occur over the next 18 months with the creation of the approximate 350 new jobs in Switzerland, mainly in the development and manufacture of innovative ...
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Biogen has completed an asset purchase of Phase III candidate, Cirara (intravenous glyburide), a drug to treat a severe form of ischemic stroke from Remedy Pharmaceuticals’, a New York-based pharmaceutical company focused on drugs to treat central nervous system related to edema. Under the agreement, Remedy will share in the cost of development for the target indication for Cirara  for treating large hemispheric infarction stroke. Biogen will make an upfront payment of $120 million to Remedy and may also pay additional milestone payments and royalties. The Food and Drug Administration (FDA) recently granted orphan drug designation for the drug for treating ...
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A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from Amgen, AstraZeneca, Merck & Co., Novartis, and Sanofi.  Editor's Note: This article was updated on a continuous basis for news announced from Wednesday May 17, 2017 to Tuesday May 23, 2017. EMA Advisory Committee Recommends Sanofi's Biosimilar of Insulin Lispro The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Sanofi's insulin lispro Sanofi (insulin lispro 100 units/mL) for treating adults and children who have diabetes and need ...
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A report by the European Medicines Agency (EMA) shows that in 2016, European inspectors issued non-GMP compliance statements to 11% of Indian sites visited compared to 1% globally. The information is from EudraGMDP, a database operated by the EMA that supports the exchange of information on GMP compliance as well as on manufacturing and importation authorizations conducted by regulatory authorities in the European Economic Area (EEA) (composed of he European Union member states and Iceland, Liechtenstein, and Norway).  In terms of actual inspections by EEA authorities inside the EEA  and from facilities outside of the EEA manufacturing products for ...
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Scott Gottlieb, MD, the new Commissioner of the US Food and Drug Administration (FDA), addressed his staff for the first time and outlined key priorities of the agency, including improving it through the program alignment by the Office of Regulatory Affairs, addressing drug pricing through increased competition, implementing the 21st Century Cures Act, improving the generic-drug review process, and addressing opioid abuse. With respect to the overall mission of the FDA, Dr. Gottlieb said: "... [W]e have an opportunity to greatly improve FDA’s primary and principal public health protection role through the Program Alignment being undertaken by the Office ...
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Tom Price, the US Secretary of Health and Human Services (HHS), advanced the Administration's budget blueprint in calling for increased user fees to fund the FDA rather than appropriated funding. User fees for prescription drugs, generic drugs, and biosimilars expire on September 30, 2017, and Congress has been debating and offering various measures for the level of those user fees under reauthorization of the Prescription Drug User Fee Act (PDUFA VI), the Generic Drug User Fee Amendments (GDUFA II), and the Biosimilar User Fee Amendments (BsUFA II). Those measures need Congressional reauthorization to continue.  Although there is consensus among Congress ...
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For the first time in more than 20 years, Canada is proposing changes to its drug-pricing regulations, including a proposal to introduce new, economics-based price regulation factors. In announcing the proposed regulations, Canadian officials stress two key market developments as it relates to drug pricing: (1) the emergence of higher-cost drugs, such as biologics and genetic therapies, which are putting increasing pressure on drug spending; and (2) a growing discrepancy between public list prices and lower actual market prices due to the increased use of confidential discounts and rebates. The proposed amendments are intended to reverse these trends ...
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A recent report by QuintilesIMS, commissioned by the European Commission, examines the market penetration and pricing issues of biosimilars in Europe. So what did the report show? In the 11 years since biosimilars have been approved by European regulatory authorities, there have been 28 biosimilars approved in Europe, compared to only four in the US, where a regulatory pathway lagged in development comparative to Europe. So which drugs have been approved thus far and what may the market expect to see? DCAT Value Chain Insights Inside the European biosimilars market The report describes the effects on price, volume, and market share following ...
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Thermo Fisher Scientific has agreed to acquire Patheon for $7.2 billion, inclusive of approximately $2.0 billion of net debt. So what is the impact for Thermo, Patheon, and the contract dosage-form market?. The acquisition of Patheon provides Thermo Fisher with small- and large-molecule development and manufacturing capabilities as well as formulation development and drug product manufacturing and will become part of Thermo Fisher's Laboratory Products and Services Segment. DCAT Value Chain Insights examines the proposed combined company and the market implications. Inside the deal Thermo Fisher Scientific has agreed to acquire Patheon, a contract ...
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Saneca Pharma, a contract development and manufacturing organization based in western Slovakia, has been granted a multiple dosage-form approval for the manufacture and supply of solids, semi-solids, and liquid finish dose products to Russia. The company achieved this cGMP certification following an inspection by the Federal State Institution State Institute of Drugs and Good Practices’ of Russia. The certification covers the manufacture and packaging of hard and soft-gel capsules, liquids for external use, semi-solids dry as ointments, and film coated-tablets. Source: Saneca Pharm
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Bristol-Myers Squibb (BMS) and Calithera Biosciences, a clinical-stage biotechnology company fdeveloping small-molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, have expanded their existing collaboration to evaluate Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Calithera’s CB-839 in patients with non-small cell lung cancer (NSCLC) and melanoma. CB-839 is an investigational orally administered glutaminase inhibitor currently in Phase I/II clinical studies. Preclinical data suggest that CB-839, which is designed to target a pathway to starve tumor cells of the key nutrient glutamine, may ...
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Merck KGaA announced that it will remain at its headquarters site in Darmstadt, Germany, and announced a plan to upgrade its enterprise resource planning (ERP) systems across its three businesses: healthcare, life sciences, and performance materials.  “Darmstadt is a strong site with strong prospects. Our Group headquarters are and will remain in Darmstadt. We manufacture here for all three business sectors [healthcare, life science, and performance materials]. Important research activities are based in Darmstadt, and we meanwhile have more than 10,000 employees at the site,” said Stefan Oschmann, chairman of the Executive Board and CEO of Merck KGaA, in ...
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Boehringer Ingelheim and Peking University (PKU) in China have formed a strategic partnership with the aim of jointly advancing early science innovation across a range of areas of high medical need. The partnership will implement a multi-faceted collaboration model that will consist of project-based research, a joint post-doctorate fellowship program, and a number of Boehringer Ingelheim-endowed investigators. The partnership aims to strengthen Boehringer Ingelheim’s portfolio of early and unique pipeline projects. PKU is a national comprehensive university with disciplines in the natural sciences, humanities, social sciences, technological sciences, information ...
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Boehringer Ingelheim has inaugurated its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park in Shanghai, China. The site, with first-phase investment of more than EUR 70 million ($78 million), uses mammalian cell-culture technology and will support the company's contract manufacturing business. Boehringer Ingelheim said it has made this move with the long-term goal to become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China. Since 2014, Boehringer Ingelheim China Biopharmaceuticals has been operating its GMP clinical material supply at 100-L and 500-L scales. After its ...
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