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Pharmaceutical
Vividion Therapeutics, a wholly-owned subsidiary of Germany’s Bayer, today announced it will expand its global innovation capabilities with a new research and development (R&D) center and corporate headquarters in San Diego, California. 23 July 2024
Pharmaceutical
US pharm major Eli Lilly on Friday revealed via a social media posting that it has been granted approval from the Chinese National Medical Products Administration (NMPA) to sell tirzepatide for weight loss in the country. 20 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD). 19 July 2024
Pharmaceutical
German family-owned pain specialist Grünenthal has announced significant investments in its Latin American production sites. 17 July 2024
Pharmaceutical
Zevra Therapeutics revealed that the US Food and Drug Administration (FDA) has indicated it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2, 2024, to review the New Drug Application (NDA) for arimoclomol. 15 July 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program was rejected by a federal judge. 5 July 2024
Pharmaceutical
Mochida Pharmaceutical announced that it has submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (MND-21), a highly purified eicosapentaenoic acid (EPA). 4 July 2024
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorization be revoked 29 June 2024
Pharmaceutical
Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6 have been made .... 24 June 2024
Pharmaceutical
US drugmaker Lexicon Pharmaceuticals today announced that, following multiple interactions with and recent feedback from the US Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). 21 June 2024
Pharmaceutical
The USA’s Biomedical Advanced Research and Development Authority (BARDA) has announced up to $500 million in Project NextGen funding to plan and execute multiple Phase IIb clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19. 15 June 2024
Pharmaceutical
Pfizer chief executive Albert Bourla said the pharma giant is pausing big acquisitions after spending $43 billion last year on buying Seagen, according to a Bloomberg report. 12 June 2024
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim’s new program to cap out-of-pocket costs at $35 per month for eligible patients for the company’s inhalers is now available. 1 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea. 30 May 2024
Pharmaceutical
Helsinn and Angelini Pharma have renewed their distribution and licence agreement for Aulin (nimesulide) and Mesulid (nimesulide). 28 May 2024
Pharmaceutical
Negotiators of a proposed World Health Organization (WHO) pandemic accord have been unable to reach consensus ahead of a self-imposed deadline of next week’s World Health Assembly. 25 May 2024
Pharmaceutical
Russia is experiencing a boom in demand and sales of antidepressants these days, according to recent statements by representatives of some leading local pharmacies and analysts. 21 May 2024
Pharmaceutical
A Delaware, USA, federal jury on Friday said that AstraZeneca should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, with its cancer drug Tagrisso (osimertinib), according to IP Law360. 20 May 2024
Pharmaceutical
This week, the US Centers for Medicare & Medicaid Services (CMS) announced it would hold off on a provision to rule RIN 0938-AU28 that would have required pharmaceutical manufacturers to stack discounts and rebates to report a best price for the Medicaid drug rebate program. 17 May 2024
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk is planning to test whether its weight loss drugs, including semaglutide, marketed as Wegovy, can impact alcohol use in patients with liver disease, according to Bloomberg. 15 May 2024
Pharmaceutical
Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024
Pharmaceutical
USA-based clinical-stage biopharma Traws Pharma saw its shares leap more than 150% to $12.57 as it announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024
Pharmaceutical
New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024
Pharmaceutical
Spanish plasma-based medicines maker Grifols has announced disappointing top-line data from its Phase III PRECIOSA clinical trial evaluating the potential of long-term albumin treatment with Grifols Albutein on patients with decompensated cirrhosis and ascites, sending its share down 2.4% to 9.27 euros on Friday. 23 December 2024
Pharmaceutical
Denmark has introduced a three-year agreement to regulate price ceilings for hospital medicines, aimed at providing stability for the public healthcare system and pharmaceutical companies. 23 December 2024
Pharmaceutical
French pharma major Sanofi says it has entered into a new chapter of the collaboration with South Korean firm SK bioscience in pneumococcal vaccines, with an expanded agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. 23 December 2024
Pharmaceutical
US drugmaker Vertex Pharmaceuticals’ shares were unmoved on Friday, despite receiving two new regulatory authorizations. 23 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals, to include children as young as two years old. 23 December 2024
Pharmaceutical
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
Pharmaceutical
Among significant research news last week, UK drug developer PureTech released positive new Phase IIb data on its deupirfenidone in idiopathic pulmonary fibrosis. France’s Sanofi and Israel-based Teva Pharmaceutical Industries announced encouraging new Phase IIb data for their duvakitug in inflammatory bowel disease. Meanwhile, Vertex Pharmaceuticals released Phase II results for its investigational sciatica treatment suzetrigine that failed to impress. Also of note, AbbVie announced strong Phase III results of tavapadon in early Parkinson’s disease. 22 December 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Duvyzat (givinostat) to treat Duchenne muscular dystrophy (DMD). 22 December 2024
Pharmaceutical
San Diego, USA-based Neurocrine Biosciences today announced the launch of its Crenessity (crinecerfont) in the USA. 20 December 2024
Pharmaceutical
Denmark’s Zealand Pharma has been hit with a complete response letter (CRL) from the US regulator for glepaglutide, a long-acting GLP-2 analog. 20 December 2024
Pharmaceutical
Denmark’s Novo Nordisk today announced headline results from REDEFINE 1, a Phase III trial in the global REDEFINE program, which it said were positive, but failed to impress investors, who pushed the firms shares down 19% to 601.30 kroner. 20 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). 20 December 2024
Pharmaceutical
US pharma giant Merck has announced top-line results from two pivotal Phase III trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL). 20 December 2024
Pharmaceutical
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
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