Industry news
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Repairing heart damage by targeting the stress response
12 March 2019
When the heart is starved of oxygen during cardiac arrest, its muscle puts out stress signals that ultimately cause heart cells to die. The resulting damage often leads to chronic heart failure.
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EMA Validates Application of Merck & Pfizer’ Drugs Combination
11 March 2019
Merck and Pfizer Inc. today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the treatment of patients with advanced renal cell carcinoma (RCC). With this validation, the application is complete, and the EMA will now begin the review procedure.
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Merck and Pfizer Join Pancreatic Cancer Treatment Collaboration
11 March 2019
BioXcel Therapeutics, Inc. (“BTI”) announced the addition of Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the USA and Canada, and Pfizer Inc.to its Nektar Therapeutics clinical collaboration to evaluate a novel triple combination therapy in pancreatic cancer. The collaboration now includes avelumab, BXCL701 and NKTR-214 as a potential combination therapy for pancreatic cancer. Avelumab is a human anti-programmed death ligand (PD-L1) co-developed and co-commercialized by Merck KGaA Darmstadt, Germany and Pfizer.
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FAS Recommendation for Advertising OTC Drugs in Russia
07 March 2019
During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines.
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Pfizer to License AnTolRx Type 1 Diabetes Therapy
07 March 2019
AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. has exercised the option granted under a June 2016 agreement to license an immune tolerance therapy from AnTolRx’s Type 1 diabetes research program.
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EMA Recommended First Med for FCS
06 March 2019
The European Medicines Agency has recommended granting a conditional marketing authorisation (CMA) for Waylivra (volanesorsen), the first medicine for the treatment of the familial chylomicronaemia syndrome (FCS). FCS is a rare genetic disease that prevents the body from breaking down fats (lipids). Patients with this condition have extremely high levels of triglycerides in their blood. This causes a range of symptoms including for instance severe abdominal pain, potentially fatal attacks of acute pancreatitis, hepatosplenomegaly, diabetes, lack of concentration, memory loss and fat-filled spots on the skin (called xanthomas).
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Spanish AEMPS and Russian “SID & GP”Agreed on Cooperation
06 March 2019
In Moscow, an agreement was signed between the State Institute of Drugs and Good Practices (SID & GP) and the Spanish Agency of Medicines and Medical Devices (AEMPS). Under the agreement, the two organizations will cooperate in part of inspections of pharmaceutical facilities for compliance with GMP guidelines and in taking measures against substandard, counterfeit medicines.
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Russian Companies are Fined for Anticompetitive Agreements
05 March 2019
Vesta Pharm Ltd. and Pharm Project Ltd. are fined for an anticompetitive agreements with medical organizations who were ordering parties for medicinal supplies. In accord with the agreement, the ordering parties sent the first parts of auction applications to the staff of those companies that would simply put down the necessary wording to eject applications of the entities not involved in the collusion. Then the ordering parties would include their exact phrasings to the Evaluation Protocol on the first parts of the bids.
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05 March 2019
Investors ended 2018 with a sour outlook for biopharma, as fourth-quarter economic worries erased massive share-price gains the sector had enjoyed in the first half of the year. Dealmaking was down during the year, as were licensing deals.
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04 March 2019
Investors ended 2018 with a sour outlook for biopharma, as fourth-quarter economic worries erased massive share-price gains the sector had enjoyed in the first half of the year. Dealmaking was down during the year, as were licensing deals.
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Drug Labeling Session Was Held in Russia
20 March 2019
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ACC: BMS, Pfizer's Eliquis tops warfarin in high-risk afib subgroup
20 March 2019
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Patient Input and Patient Preference Studies
20 March 2019
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Patient Support Programs: Cost, Benefit, and Resourcing
19 March 2019