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
Netherlands-incorporated generics major Mylan and Indian biotech Biocon are a step closer to gaining approval for a biosimilar version of Herceptin (trastuzumab) in the USA. 11 January 2017
Merck & Co today announced that the US Food and Drug Administration has accepted for review a supplemental Biologics License Application (sBLA) for its dual immuno-oncological/chemotherapeutic treatment candidate. 11 January 2017
The European Commission has granted marketing authorization for Fiasp (fast-acting insulin aspart for the treatment of diabetes in adults. 10 January 2017
Excitement at opportunities, dread and doubts over what exactly the presidency of Donald Trump will mean for pharma all feature in predictions for the industry in 2017 expressed by an expert panel brought together by a pharma events organiser. 10 January 2017
Shares in Egalet rose sharply as the company received US Food and Drug Administration approval for Arymo ER (morphine sulfate), a new long-acting opioid, before falling back as details of the label were released hours later. 10 January 2017
Dr Nicola Davies explores the market access steps taken by companies such as Takeda to make medicines available and affordable for high priority patient populations. 10 January 2017
Swiss pharma giant Roche has edged closer to gaining approval from the US Food and Drug Administration (FDA) for a second bladder cancer indication with Tecentriq (atezolizumab). 9 January 2017
US-based AcelRx believes that its lead investigational compound ARX-04 has the potential to produce over $1 billion in revenue in the US. 9 January 2017
Last week, the Spanish trade group Farmaindustria, the Ministry of Finance and Public Function and Health and the Ministry of Social Services and Equality signed the Agreement that renews, for 2017, the Protocol of Collaboration agreed back in November 2015 with the common objective to ensure the sustainability of the National Health System (NHS) and the access of citizens to pharmaceutical innovations. 9 January 2017
The biopharmaceutical industry's desire for inorganic growth is expected to intensify an already heated mergers and acquisitions (M&A) environment in 2017. 9 January 2017
Shares of biotech Innocoll Holdings tumbled as much as 65% on December 30, after the US Food and Drug Administration issued a refusal to file letter for the company's product candidate for a treatment for post-surgical pain Xaracoll. 8 January 2017
The US Office of Congressional Ethics (OCE) and the US Securities and Exchange Commission (SEC) should look more closely at the stock trading activity of US Representatives Tom Price (Republican, Georgia.) and Chris Collins (Republican, New York) for conflicts of interest and possible insider trading, consumer advocacy Public Citizen said in a letter yesterday. 6 January 2017
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which concludes that an additional benefit for Kisplyx (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC, or kidney cancer) versus the established comparator therapy. 5 January 2017
Wockhardt on Wednesday revealed that it had received another US Food and Drug Administration warning letter for its active pharmaceutical ingredient plant in Ankleshwar, Gujarat. 5 January 2017
Pharmaceutical companies are increasingly using social media as a platform for their communications and advertising, enabling them to engage more actively with consumers and healthcare professionals, notes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 5 January 2017
Ocular Therapeutix will submit a New Drug Application (NDA) to the US Food and Drug Administration for Dextenza (dexamethasone) in the first quarter of 2017. 5 January 2017
Bayer has announced that its Supplemental New Drug Application (sNDA) for Stivarga (regorafenib) will be reviewed under the US Food and Drug Administration’s priority review scheme. 4 January 2017
Swedish Orphan Biovitrum has received approval from Health Canada for its Orfadin (nitisinone) capsules for hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 4 January 2017
Ireland-incorporated drugmaker Allergan finished Tuesday’s trading 3% up at $216.19 as markets and analysts reacted to drug price rises which the company limited to single figures – but only just. 4 January 2017
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
Kezar Life Sciences has paused its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 7 October 2024