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The US Food and Drug Administration is announcing the availability of a draft guidance for industry titled, “Fabry Disease: Developing Drugs for Treatment." 9 August 2019
Pharmaceutical
Japanese pharma major Astellas today announced that David Fryrear joined its Medical and Development (M&D) organization as senior vice president and head of the clinical and research quality assurance (CRQA) organization in June 2019. 6 August 2019
Pharmaceutical
The European Medicines Agency (EMA) has told marketing authorization holders of medicines containing liposomal drug delivery systems to submit a variation to change the names of these medicines as soon as possible before the end of September. 2 August 2019
Pharmaceutical
UK pharma major GlaxoSmithKline says it has completed its transaction with US giant Pfizer to combine their consumer healthcare businesses into a world-leading joint venture. 1 August 2019
Pharmaceutical
The US regulator has sent a Form 483 warning to the India-based active pharmaceutical ingredient (API) producer Dr. Reddy’s Bollaram, regarding a number of deficiencies including a failure to respond to complaints about out-of-specification (OOS) results. 31 July 2019
Pharmaceutical
Paladin Labs, an operating company of Endo International, has acquired exclusive rights to commercialize and distribute pracinostat in Canada from Swiss pharma group Helsinn following Canadian regulatory approval. 31 July 2019
Pharmaceutical
The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) have signed a memorandum of understanding aimed at improving collaboration and knowledge sharing. 30 July 2019
Pharmaceutical
The US Food and Drug Administration today issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry. 29 July 2019
Pharmaceutical
The US Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. 29 July 2019
Pharmaceutical
A California judge slashed a more than $2B award against Germany’s Bayer to $86.7 million in a case where a husband and wife each blamed their non-Hodgkin lymphoma diagnoses on the company's Roundup weedkiller, according to a Wall Street Journal report. 26 July 2019
Pharmaceutical
Pfizer’s Japanese business and Takeda Pharmaceutical have agreed to terminate co-promotion for the rheumatoid arthritis/juvenile idiopathic arthritis therapy Enbrel (etanercept). 26 July 2019
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of Amarin Pharma’s Vascepa (icosapent ethyl) and Johnson & Johnson subsidiary Janssen Pharmaceuticals’ Xarelto (rivaroxaban) – co-marketed with Bayer, additive cardiovascular disease (CVD) therapies. 25 July 2019
Pharmaceutical
Ending a six month search, GlaxoSmithKline today announced that Jonathan Symonds will succeed Sir Philip Hampton as non-executive chairman of the GSK board with effect on September 1, 2019. 24 July 2019
Pharmaceutical
WuXi AppTec subsidiary STA Pharmaceutical has passed two inspections from the US Food and Drug Administration (FDA). 23 July 2019
Pharmaceutical
Having terminated a proposed merger plan with FSD Pharma last December, Israel-based Therapix Biosciences, a clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, has now signed a letter of intent (LiI) for a proposed merger with Canada’s Destiny Biosciences Global Corp. 23 July 2019
Pharmaceutical
The US Food and Drug Administration has released a final guidance, “Postmarketing Safety Reporting for Combination Products,” for applicants of combination products - products composed of two or more different types of medical products (ie, drug, device or biologic) - to further clarify how they can comply with the 2016 final rule on post-marketing safety reporting requirements (PMSR) for combination products. 23 July 2019
Pharmaceutical
France’s Sanofi has signed an exclusive over-the-counter (OTC) agreement with Roche for the rights to Tamiflu (oseltamivir) in the USA. 23 July 2019
Pharmaceutical
Servier’s electronic health division, WeHealth Digital Medicine, has announced a partnership with Lucine, a firm specializing in digital therapeutics. 22 July 2019
Pharmaceutical
Responding to a reported shortage of the 0.3 mg format EpiPen (epinephrine) auto-injector, the Canadian medicines regulator has warned of the potential for temporary supply constraints in coming months. 19 July 2019
Pharmaceutical
US biopharma major AbbVie today announced that Todd Manning has been named general manager of AbbVie UK. 19 July 2019
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) in patients with agammaglobulinemia or hypogammaglobulinemia disorders, from domestic drug giant Takeda Pharma 27 December 2024
Pharmaceutical
Japanese drugmaker Kaken Pharmaceutical has entered into a license agreement with US healthcare giant Johnson & Johnson for the global development, manufacturing and commercialization of a STAT6 program that Kaken is developing. 27 December 2024
Pharmaceutical
Akums, India’s largest contract development and manufacturing organization (CDMO), has signed a strategic agreement with an undisclosed global pharmaceutical company. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 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
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