US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
The uncertainty over the state of the pharmaceutical industry following Brexit will favor internationally focused professionals, according to NonStop Recruitment. 13 July 2016
Pfizer yesterday revealed that Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) received US Food and Drug Administration approval for an expanded age indication to include adults 18 through 49 years of age. 13 July 2016
Patient access to biosimilar medicines will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration’s Arthritis Advisory Committee. 13 July 2016
A biosimilar version of Pfizer and Amgen’s arthritis drug Enbrel is ‘highly similar’ to the reference product, according to US Food and Drug Administration (FDA) staff briefing documents. 12 July 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance recommending Belgian drugmaker UCB’s Cimzia (certolizumab pegol). 12 July 2016
The Canadian subsidiary of Anglo-Swedish pharma major AstraZeneca has received approval for medicines regulator Health Canada for Tagrisso (osimertinib) once-daily tablets. 12 July 2016
The Russian government is considering introducing a three-stage procedure for the public procurement of drugs, according to recent statements of an official spokesman of Denis Manturov, Russia’s Minister of Industry and Trade. 12 July 2016
Ireland-incorporated Shire has received US Food and Drug Administration approval for Xiidra (lifitegrast ophthalmic solution) 5% as a treatment for dry eye disease. 12 July 2016
The UK government has brought in pharma industry chiefs to co-chair a ministerial group aimed at ensuring Brexit does not damage the country’s life sciences sector. 11 July 2016
At its July meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety referral on one medicine, and initiated three new safety referrals. 11 July 2016
A biosimilar version of the world’s best-selling drug is ‘highly similar’ to the reference product, according to a US Food and Drug Administration staff briefing documents published ahead of tomorrow’s committee meeting. 11 July 2016
Recent changes as a result of the introduction of medical price reforms in China are expected to eliminate public hospital mark-ups on drug prices and cut prices for medical examinations and supplies by the end of 2020, according to a guideline issued by the National Development and Reform Commission (NDRC) last week. 11 July 2016
The Indian government is looking to widen the scope of price controls on pharmaceuticals. In a move that could create another potential hurdle for multinational drug companies doing business in India, the Department of Pharmaceuticals is examining a proposal to look into the pricing of patented drugs in the country, reports The Pharma Letter’s India correspondent. 11 July 2016
All Periodic Safety Update Reports (PSURS) for centrally and nationally authorized medicinal products in Europe must be submitted via the PSUR Repository as of June 13, 2016. 11 July 2016
More than $1 billion was wiped from the market value of biotech groups racing to develop a revolutionary cancer treatment, after one of the companies, Juno Therapeutics, revealed that three young patients had died after receiving its experimental therapy on a clinical trial. 10 July 2016
Bosses at Japanese pharma major Eisai are angry at the exclusion of its oncology drug Lenvima (lenvatinib) from the Cancer Drugs Fund (CDF) in England. 8 July 2016
The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ Epclusa (sofosbuvir 400/velpatasvir), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 8 July 2016
Knowing when to prescribe biosimilars is a massive issue internationally, and action is being taken on the issue in the UK to make sure they are used appropriately and in consultation with patients. 8 July 2016
The deaths of two patients has led the US Food and Drug Administration to put a clinical hold on the Phase II trial of JCAR015, a leukemia drug being developed by USA-based biopharma company Juno Therapeutics. 8 July 2016
The US Food and Drug Administration has approved Xolair (omalizumab), from Roche subsidiary Genentech, to treat moderate to severe persistent asthma in children six to 11 years of age. 8 July 2016
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024