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
By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. 12 June 2016
The European Ombudsman, Emily O'Reilly, has welcomed increased transparency in the clinical testing of Humira (adalimumab), one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports. 10 June 2016
The Indian Pharmacopeia Commission (IPC) has released the national reference standards, specifically referred as the Indian Pharmacopoeia Reference Substances (IPRS Vaccines), the first such initiative to be undertaken of its kind. 9 June 2016
New Zealand’s Pharmaceutical Management Agency, PHARMAC, today announced funding of six new treatments across important areas of health, including major advancements in the treatment of hepatitis C. 9 June 2016
Trade group AusBiotech said today it has provided a submission in response to the Australin Productivity Commission’s Intellectual Property (IP) Arrangements Draft Report, disagreeing with numerous recommendations in regard to patents and data protection. 9 June 2016
There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for active pharmaceutical ingredient (API) exporters to the European Union, according to Brand India Pharma. 9 June 2016
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has today published provisional guidance, within its Appraisal Consultation Document, on aflibercept (Eylea). 8 June 2016
The European Commission has approved the use of Swiss pharma giant Roche’s Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with epidermal growth Factor Receptor (EGFR)-activating mutations. 8 June 2016
US Food and Drug Administration advisory panels yesterday voted 14 to three to recommend approval of Vantrela ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 8 June 2016
US-based Adamis Pharmaceuticals (Nasdaq: ADMS) has suffered a share-busting setback in its New Drug Application (NDA) for its epinephrine injection pre-filled single dose syringe (PFS) product for emergency treatment of acute anaphylaxis, a severe allergic reaction. 7 June 2016
A pilot study has shown the huge differences in retail prices of cancer drugs in different countries, and highlighted the burden the cost puts on patients in many parts of the world. 7 June 2016
US RNA-based drug developer Sarepta Therapeutics says that the US Food and Drug Administration has requested additional data relating to its regulatory approval for its much delayed Duchenne muscular dystrophy drug candidate. 7 June 2016
Privately-held Swiss biotech Novimmune has announced that its lead program, NI-0501, has been declared eligible for the PRIME (PRIority MEdicine) scheme of the European Medicines Agency (EMA) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH). 6 June 2016
The US Food and Drug Administration has approved marketing of a new fixed-dose combination of two FDA-approved blood pressure lowering agents. 6 June 2016
In Russia, pharma patents account for a large share of patent portfolios. In 2015 the government considered a draft bill on compulsory licensing of patented medicines, writes Vladimir Biriulin of law firm Gorodissky & Partners on the International Law Office site. 6 June 2016
The progress that has been made globally in developing treatments for rare diseases in the last 20 years is enormous. At the end of the 20th century there were just eight medicines approved in Europe for diseases compared to around 200 today. But there is still a long way to go. 6 June 2016
Plucky US microcap Celator Pharmaceuticals has rewarded its investors this morning with a 70% stock price rise after agreeing to a $1.5 billion all-cash takeout offer from Jazz Pharmaceuticals over the holiday weekend. 5 June 2016
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 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