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
In early 2016, the USA’s Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B, according to McKenzie Cato and David Gibbons writing on Hyman, Phelps & McNamara on its FDA Law Bog. 11 October 2017
Drug pricing, subject of impassioned presidential Tweets not so long ago, has ceded priority in recent months, amid the furore over Obamacare replacement efforts. 10 October 2017
Shares of Poland’s largest biotech firm Selvita plunged 17.2% to 45.12 zlotys on Monday, after the company revealed receipt of a clinical hold on the development of its acute myeloid leukemia (AML) drug by the US regulator. 10 October 2017
The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). 10 October 2017
The China Food and Drug Administration has announced far-reaching reforms to its regulatory system, that are expected to speed up approvals of medical technologies in the country. 9 October 2017
The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use. 9 October 2017
Shares in AstraZeneca edged higher in early dealing today, on the news that US regulators have granted its Tagrisso (osimertinib) Breakthrough Therapy designation and its European peer has accepted the marketing application for its Imfinzi (durvalumab). 9 October 2017
The level of rebates and claw-backs that pharmaceutical companies in Greece are required to pay is unique by European standards and indicative of the over-taxation that is killing the industry. 9 October 2017
The packaging of prescription-only medicinal products must have safety features from February 9, 2019 onwards, the Dutch Medicines Evaluation Board (CBG) has reminded players. 9 October 2017
By 2050, the world’s population aged 60 years and older is expected to reach 2 billion – a vast leap from the 900 million elderly citizens living across the globe today. 7 October 2017
Life sciences companies are facing familiar business risks, according to their most recent 10-K filings. But revolutionary forces - driven by innovations in technology, regulatory bodies, consumers, legislators and healthcare providers - will require new ways of thinking about risk mitigation. 6 October 2017
Yet another congressional push to repeal and replace the Affordable Care Act has failed as, for a second time, Republicans opted to withdraw proposals rather than face the humiliation of defeat. 6 October 2017
At present, two out of three people diagnosed with cancer survive at least five years. Between 1991 and 2011 deaths from cancer have fallen by 21% across the EU5 (UK, France, Germany, Spain and Italy). 6 October 2017
Venclyxto (venetoclax) is backed by compelling data in chronic lymphocytic leukemia (CLL) but in order to reach English patients, it has needed the pathway provided by the Cancer Drugs Fund (CDF) . 5 October 2017
Two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) multiple sclerosis drug Copaxone (glatiramer acetate) 40mg/mL in Europe. 5 October 2017
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has made his support for increasing the availability of generic drugs very clear since assuming office in May. 5 October 2017
The UK High Court has rejected a bid from the the British pharma industry to prevent the National Institute for Health and Care Excellence from imposing new rules around price negotiations. 5 October 2017
Russia’s pharmaceutical market is one of the fastest growing in the world and is expected to reach $36.61 billion by 2021, says a leading business information and analytics provider. 5 October 2017
In what is something of a criticism of the European Medicines Agency, a research team has found most cancer drugs are approved by the EMA using only surrogate measures which, although indicators, are not strong predictors of survival – whether living longer or feeling better. 5 October 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