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Merck & Co. has entered into a clinical-trial collaboration with Atara Biotherapeutics, a South San Francisco-based biopharmaceutical company, to evaluate Atara Bio's ATA129, an allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T lymphocyte (CTL), in combination with Merck's Keytruda (pembrolizumab), an anti-programmed death receptor-1 (PD-1) anti-cancer therapy, for treating platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma. Keytruda is a blockbuster drug for Merck with 2016 sales of $1.4 billion. The collaboration includes a Phase I/II trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ...
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Samsung Bioepis, an Incheon, South Korea-headquartered biopharmaceutical company that is a joint venture between Samsung BioLogics and Biogen, has received approval from the US Food and Drug Administration (FDA) for Renflexis (infliximab-abda), a biosimilar referencing Johnson & Johnson’s (J&J) blockbuster drug, Remicade (infliximab), across all eligible indications. Remicade is the top-selling drug in J&J’s pharmaceuticals division with 2016 sales of $1.6 billion. Samsung Bioepis’ infliximab biosimilar has also been approved for marketing in 28 European Union (EU) member states as well as in Norway, Liechtenstein, Iceland, Australia, and Korea. Samsung Bioepis ...
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The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) released a new report on the trends from its inspection activity of dosage-form manufacturing plants and related GMP deficiencies in 2016. Quality systems and sterility assurance were leading areas for GMP deficiencies. The report included data based on 324 inspections by the MHRA (242 inspections in the UK and 82 overseas). Among the most cited deficiency groups in 2016 were quality systems (1259 total deficiencies: 38 critical, 449 major, and 772 other); sterility assurance (386 total deficiences: 34 critical, 190 major, and 162 others); and production (754 total deficiencies: 20 critical, ...
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The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a report on the results of a recently completed joint pilot program for assessing applications containing Quality by Design (QbD) elements.The aim of this program was to facilitate the consistent implementation of QbD concepts introduced through International Council for Harmonization (ICH) Q8, Q9 and Q10 documents and harmonize regulatory decisions across the two regions. To facilitate this, assessors/reviewers from the US and European Union (EU) exchanged their views on the implementation of ICH concepts and relevant regulatory requirements using actual applications ...
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Fujifilm Corporation plans to invest approximately Japanese Yen 14 billion ($130 million) in the US and UK for two new facilities to increase production capacity and process development capabilities for its Bio contract development and manufacturing organization (Bio CDMO) Division, which Fujifilm launched as a standalone unit on March 1, 2017. The $130-million investment includes a recently completed Japanese Yen 10-billion ($93-million) cGMP production facility at its Fujifilm Diosynth Biotechnologies Texas site. Fujifilm plans to invest an additional Japanese Yen 3 billion ($28 million) to install mammalian cell culture bioreactors in this facility, ...
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Through early April, the FDA's Center for Drug Evaluation and Research had approved 13 new molecular entities (NMEs), which far exceeds the pace set in 2016 when the FDA approved 22 NMEs for the full year. So what products are contributing to the uptick? Among the large pharmaceutical companies, Roche received approval for a multiple sclerosis drug and Sanofi, along with its partner, Regeneron Pharmaceuticals, received approval for a drug to treat a form of eczema. So what other NMEs have cleared the regulatory hurdle thus far in 2017? DCAT Value Chain Insights takes the score. NME approvals off to a fast start The number of approvals by the ...
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Which drugs entering the market are poised as blockbusters? DCAT Value Chain Insights examines the contenders for this year. A recent analysis by Clarivate Analytics points to nine drugs entering the market this year that are expected to reach sales of at least $1 billion by 2021. So which drugs are making the mark? Leaders of the pack The Clarivate Analytics study, Drugs to Watch 2017,   points to eight drugs projected to be launched in 2017 that are projected for blockbuster status (defined as sales of $1 billion or more) by 2021, and one additional drug slated for near blockbuster status by 2021 (see Table I at end of article ). Ranked ...
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The Pharmaceutical Research and Manufacturers of America (PhRMA) provided comments to a recent report by the US Food and Drug Administration (FDA) in which the agency assessed its communication and transparency of information with industry for new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs). The FDA released the report in November 2016  as part of its assessment of  agency performance under the Prescription Drug User Fee Act (PDUFA). Part of PhRMA's comments related to the inspection process for drug-manufacturing facilities.  In its comments, PhRMA said it agreed with the FDA's final report finding ...
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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 Novartis. Editor's Note: This article is updated on a continuous basis for news announced from Wednesday April 12, 2017 to Tuesday April 18, 2017. Novartis’ CAR-T Therapy Granted Breakthrough Therapy Status Novartis has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for tisagenlecleucel-T (CTL019), its investigational chimeric antigen receptor T cell (CAR-T) therapy, for treating relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL). This marks the second ...
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Cobra Biologics, a Keele, UK-headquartered contract development and manufacturing organization for biologics and pharmaceuticals, plans to invest up to £15 million ($19 million) over the next two years to expand biopharmaceutical manufacturing operations at its sites in the UK and Sweden. The investment involves a phased expansion plan that supports the company’s research and development activities in developing viral vector and DNA plasmid production platforms. The initial phase, which will be in the UK, will extend the company’s viral vector Phase III and commercial manufacturing capabilities. The second phase, to be conducted in Sweden, will double capacity ...
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Novartis has entered into a clinical-trial agreement with Allergan to conduct a Phase IIb study involving the combination of a Novartis farnesoid X receptor (FXR) agonist and Allergan's cenicriviroc (CVC) for treating non-alcoholic steatohepatitis (NASH), a progressive form of non-alcoholic fatter liver disease. CVC is a once-daily, oral immunomodulator that blocks two chemokine receptors involved in inflammatory and fibrogenic pathways. The compound is ready for Phase III study and has been granted fast track designation by the US Food and Drug Administration (FDA) for treating NASH and liver fibrosis. Novartis is developing FXR agonists for treating chronic ...
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The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Eli Lilly and Company and its partner, Incyte, a Wilmington, Delaware-based biopharmaceutical company, for their new drug application (NDA) of baricitinib, an investigational oral medication for treating moderate-to-severe rheumatoid arthritis (RA), indicating that the FDA is unable to approve the application in its current form. The FDA is specifically seeking additional clinical data to determine the most appropriate doses of the drug and to further characterize safety concerns across treatment arms. Lilly and Incyte submitted the NDA for baricitinib to the FDA in January ...
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Merck & Co. has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its supplemental new drug applications (sNDAs) for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl), and Janumet XR (sitagliptin and metformin HCl extended-release), Merck’s blockbuster anti-diabetes drugs. Januvia, currently indicated as an adjunct to diet and exercise to improve glycemic control in Type 2 diabetes mellitus, and Janumet/Janumet XR, combination sitagliptin and metformin drugs approved for the same indication, are top-selling products in Merck’s diabetes franchise. Januvia had 2016 sales of $3.9 billion and Janumet had 2016 ...
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Leaders of the US House of Representatives and Senate health committees have released a discussion draft of bipartisan legislation,  The FDA Reauthorization Act of 2017,  for reauthorizing the US Food and Drug Administration user fee programs for pharmaceuticals, generic drugs, and biosimilars. The proposed legislation comes as the House and Senate consider legislation for 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), which are set to expire on September 30, 2017 and which need reauthorization by Congress to continue.  The discussion ...
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Recipharm has appointment Henrik Stenqvist as Recipharm’s new executive vice oresident and chief financial officer (CFO), effective on April 24, 2017. Mr. Stenqvist will be based at the company’s headquarters in Stockholm, Sweden and reports to Thomas Eldered, chief executive officer of Recipharm. Mr. Stenqvist brings 24 years’ finance and management experience to Recipharm. Prior to joining Recipharm he served as CFO of the Meda Group and held other leading finance positions in the pharmaceutical industry. Source: Reciphar
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GE Healthcare has invested in cold-chain technology and automated manufacturing software through its acquisition of Asymptote, a Cambridge, UK-based company that specializes in cryochain technology for sensitive cellular therapies, and equity investment in Zenith Technologies, a Cork, Ireland-based technology company delivering manufacturing software systems. The acquisition of Asymptote includes an integrated suite of cryochain hardware, software, and consumables designed to maintain the potency of cellular therapies by enabling ultra-low temperature freezing during production through to thawing at the clinic prior to patient administration. Asymptote’s ...
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Ajinomoto OmniChem, a wholly owned subsidiary of Ajinomoto Co. and a Wetteren, Belgium-headquartered contract development and manufacturing organization for small-molecule active pharmaceutical ingredients, has completed a commercial-scale manufacturing project under which it adapted to a continuous flow chemistry platform from a traditional multi-step batch process through the mobile installation of a continuous flow platform at its pilot plan facility in Wetteren. In making the announcement, the company noted several advantages of continuous manufacturing over batch manufacturing: reduction of overall processing time, increased reaction selectivity, improved ...
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Indoco Remedies, a Mumbai, India-headquartered active pharmaceutical ingredient (API) and finished dosage form manufacturer, has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the company’s sterile injectable drug manufacturing facility in Goa, India. The violations were noted during a FDA inspection of the Goa facility from August 31, 2016 to September 4, 2016, and the agency has reviewed Indoco’s September 20, 2016 response and has acknowledged receipt of the company’s subsequent correspondence. The FDA observed specific violations including, but not limited to, failure to establish and follow adequate written ...
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche and Neurocrine Biosciences. Editor's Note: This article is updated on a continuous basis for news announced from Wednesday April 12, 2017 to Tuesday April 18, 2017. FDA OKs New Indication for Roche’s Bladder Cancer Drug Genentech, a member of the Roche Group has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Tecentriq (atezolizumab) to treat locally advanced or metastatic urothelial carcinoma (mUC) in patients who are not eligible for cisplatin chemotherapy. Tecentriq was previously approved ...
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Bristol-Myers Squibb (BMS) has entered into two separate agreements, respectively with Roche and Biogen, to license two of its compounds in deals worth more than $1 billion, collectively. BMS is licensing adnectin, an anti-myostatin compound in development for Duchenne muscular dystrophy (DMD), to Roche and an anti-eTau compound under development for treating progressive supranuclear palsy (PSP), a brain disorder, to Biogen. Under the agreement to license adnectin to Roche, Roche will pay BMS an upfront payment of $170 million with potential milestone payments of up to $205 million. Under the Biogen licensing agreement, Biogen will pay BMS an upfront payment ...
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