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
India’s Department of Pharmaceuticals’ (DoP) draft Pharmaceuticals Policy has been set out to further the key aims of Prime Minister Narendra Modi of making it easier to do business in the drug development industry, and to boost the Make in India program. 21 August 2017
The European Commission today approved the extension of the indication for USA-based Alexion Pharmaceuticals’ Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 21 August 2017
Eliciting considerable comment last week was news of UK pharma major GlaxoSmithKline pulling out of its deal with Ionis Pharmaceuticals on inotersen; Mylan reaching a settlement with the US Justice Department over classification of its EpiPen; another setback for Ophthotech’s eye drug Fovista; expanded indications for AstraZeneca and Merck & Co’s cancer drug Lynparza; and US approval for Pfizer’s leukemia treatment Besponsa. 20 August 2017
On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices. 19 August 2017
Nigeria’s Minister of Health, Isaac Adewole, has said the federal government is determined to stop the sale of drugs in open markets in the country at the end of 2018. 19 August 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing the way statements about drug safety are presented in pharmaceuticals advertising. 18 August 2017
Japanese drugmaker Ono Pharmaceuticals has been granted approval from the Taiwan Food and Drug Administration to market Opdivo in a fourth indication, head and neck cancer. 18 August 2017
Hours after US pharma giant Pfizer announced the news of regulatory approval for its drug Besponsa (inotuzumab ozogamicin) in the USA, the company suffered a setback with its attempts to sell the drug in the UK. 18 August 2017
In timely fashion, US pharma giant Pfizer has received US Food and Drug Administration (FDA) approval for Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 18 August 2017
US biotech Amicus Therapeutics says the Australian Therapeutic Goods Administration (TGA) has approved its Galafold (migalastat) for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. 18 August 2017
On the morning of August 16,2017, Wu Zhen, vice minister of the China Food and Drug Administration (CFDA), met with visiting Dr Ian Hudson, the chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and his delegation. 18 August 2017
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of a proposal to fund pemetrexed for the treatment of mesothelioma and non-small cell lung cancer (NSCLC) in conjunction with the awarding of pemetrexed tender bids as part of PHARMAC’s 2015/16 annual Invitation to Tender. 18 August 2017
Harriet Lewis, medicines optimization lead for UK trade group the Association of the British Pharmaceutical Industry (ABPI), looks at the impact of biosimilar competition and what comes next, in an Expert View piece. 17 August 2017
The genomics-based drug discovery company Exelixis has submitted for regulatory approval to market Cabometyx in a new indication in the USA. 17 August 2017
Canada’s Valeant Pharmaceuticals International says the US Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida, as part of a forthcoming Establishment Inspection Record for the facility. 17 August 2017
A new coagulation reversal agen, Praxbind (idarucizumab) from German family-owned pharmaceutical company Boehringer Ingelheim, is now being used in Brazil, following marketing clearance earlier this year. 17 August 2017
Biocon, an Indian drugmaker that together with Netherlands-headquartered Mylan is a frontrunner in the race to take big-selling biosimilars to major markets, has suffered a damaging blow affecting two of its oncology submissions in Europe. 16 August 2017
Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings, the US Food and Drug Administration announced today. 16 August 2017
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has responded to yesterday’s release of a study published in JAMA, questioning the US Food and Drug Administration’s Accelerated Approval pathway. 16 August 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