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
Steve Bates, the chief executive of UK trade group The BioIndustry Association (BIA), spoke of his opposition to the UK leaving the European Union (EU) prior to last year’s referendum, saying it would be damaging for the biopharma industry. 29 March 2017
US specialty pharma company Acorda Therapeutics has released positive results from two ongoing, long-term safety studies of CVT-301 in people with Parkinson’s disease. 29 March 2017
The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 29 March 2017
US pharma giant Pfizer has received marketing authorization from the European Commission for its Xeljanz (tofacitinib citrate) 5mg twice daily oral tablets in combination with methotrexate (MTX) for moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. 29 March 2017
The US Food and Drug Administration has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). 29 March 2017
The US Food and Drug Administration has accepted the New Drug Application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. 29 March 2017
NDA Group announced findings from its fourth annual comparison of drug approvals in the European Union and the USA, ahead of this year’s DIA EuroMeeting in Glasgow, Scotland. 29 March 2017
Eagle Pharmaceuticals has announced the US Food and Drug Administration will review its filing for Ryanodex (dantrolene sodium), and has given the therapy priority review designation. 29 March 2017
The UK’s cost-effectiveness watchdog the National Institute for Health and Care Excellence has issued its final guidance on Onivyde (irinotecan liposomal) combination therapy, recommending against routine use in the National Health Service (NHS). 28 March 2017
A US Congress Subcommittee has heard that pharmaceutical companies can delay competition in the generics space by abusing FDA rules designed to enhance safety. 28 March 2017
A Viagra (sildenafil citrate) alternative, selected painkillers and travel vaccines are among items which the National Health Service (NHS) in England is set to cease prescribing. 28 March 2017
Tesaro saw its shares gain 5.9% to $156.73 in after-hours trading on Monday after the US Food and Drug Administration announced approval for its new oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor intended for the treatment of ovarian cancer. 28 March 2017
The German Federal Joint Committee (G-BA) has confirmed the additional benefit of Kisplyx (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) versus everolimus alone. 28 March 2017
The French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has approved Eprex (epoetin alfa) for the treatment of symptomatic anemia. 28 March 2017
European regulators have accepted Kiadis Pharma’s Pediatric Investigation Plan (PIP) for ATIR101 (allodepleted T-cell immunotherapeutics), an important regulatory milestone. 28 March 2017
The UK BioIndustry Association (BIA) is leading a UK delegation from the biotech sector on a discovery trip to see how Switzerland works with Europe but outside of the EU, to forge new relationships and explore potential opportunities. 28 March 2017
The Australian government is reducing the price of 1,100 medicine brands listed on the Pharmaceutical Benefits Scheme. As a result, the price paid by millions of Australians for prescription medicines will be reduced, from the start of April. 27 March 2017
The urgent need to foster “Make in India for India” in Active Pharmaceutical Ingredient (API ) manufacturing to capitalize on the lost market share, reduce India’s dependency on China and establish self-sustainability, is highlighted by the ASSOCHAM (Associated Chambers of Commerce & Industry of India)-Sathguru joint study. 27 March 2017
Anglo-Swedish pharma major AstraZeneca has received marketing authorization for Tagrisso (osimertinib) in China as a first-in-class treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic non-small cell lung cancer (NSCLC). 27 March 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