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
Italian CNS-focused drug developer Newron Pharmaceuticals (SIX: NWRN) and its partners Zambon and US WorldMeds announced today that the US Food and Drug Administration and the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the FDA no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago (safinamide). 27 July 2016
GlaxoSmithKline, Britain’s largest pharma company, this morning announced £275 million ($360 million) of new investments at three of its manufacturing sites in the UK. 27 July 2016
The US Food and Drug Administration has granted approval for US pharma major AbbVie’s New Drug Spplication (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. 26 July 2016
“With the advent of e-pharmacy, there is a need to amend the Drugs and Cosmetics Act, 1940, as it does not differentiate between offline and online pharmacies," said K B Aggarwal, the Additional Secretary (Food and Drugs), Union Ministry of Health and Family Welfare, India. 26 July 2016
US ophthalmology specialist Ocular Therapeutix saw its share price plummet by 14.5% on Monday after announcing that the Food and Drug Administration (FDA) had not approved its new drug application (NDA) for Dextenza (dexamethasone insert), the company’s lead candidate. 26 July 2016
NewLink Genetics says that partner US pharma giant Merck & Co has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). 26 July 2016
The US Food and Drug Administration has granted Breakthrough therapy designation for Darzalex (daratumumab) as a treatment for previously treated multiple myeloma in combination with standard of care reigmens. 26 July 2016
The US Food and Drug Administration has lifted its clinical hold on a Phase I/II trial of CGF166, a treatment for patients with severe to profound hearing loss which is being developed by Swiss pharma giant Novartis under a licensing agreement with US-based GenVec. 25 July 2016
The Irish Pharmaceutical Healthcare Association (IPHA) has agreed a new four-year “Framework Agreement” with the government for an economic and secure supply of medicines for patients. The Agreement will see total savings of 785 million euros ($862 million) from IPHA member companies, an average of nearly 200 million euros a year. 25 July 2016
Sanofi Pasteur MSD UK says that the UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved its quadrivalent influenza vaccine (split virion, inactivated), which contains two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata) of the influenza virus. 25 July 2016
The US Food and Drug Administration has told Canada-based Valeant Pharmaceuticals International that an inspection has identified deficiencies in the manufacturing of Vesneo (latanoprostene bunod), an ophthalmic solution for open angle glaucoma or ocular hypertension. 25 July 2016
The challenges facing the pharmaceutical healthcare system and industry, in Greece as well as the urgent need to design and implement a sustainable pharmaceutical policy framework were the subject of a joint meeting held last week at the Ministry of Health. 25 July 2016
The Venezuelan government has established automatic distribution centers as part of a project to improve medical supplies in the South American country. 25 July 2016
The European Medicines Agency has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, a contract research organization (CRO) with an analytical and a clinical site located in Bangalore, India. 24 July 2016
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Lonsurf (trifluridine–tipiracil hydrochloride) for the treatment of patients with metastatic colorectal cancer who have received previous treatment. 23 July 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its July meeting. 23 July 2016
Brexit has sent shockwaves through the pharmaceutical and life science industries and although the exact extent of the fallout is not yet known, the impact is sure to be felt for many years to come. Exactly a month on from one of the most significant votes in British history, the Pharma Letter takes a look at the immediate aftermath of the decision and some of the potential long term implications. 23 July 2016
The European Medicines Agency has recommended granting marketing authorizations in the European Union for two medicines for the treatment of advanced renal cell carcinoma (kidney cancer). 22 July 2016
Puma Biotechnogy has released encouraging interim five-year invasive disease free survival results from the company's Phase III trial of PB272 (neratinib) and announced a regulatory filing. 22 July 2016
US biotech Spark Therapeutics and pharma giant Pfizer have been granted Breakthrough Therapy designation from the US Food and Drug Administration for their hemophilia B treatment SPK-9001. 22 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