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
Diurnal Group has published the results from its Phase III trial of lead product Infacort in adrenal insufficiency, a condition characterized by deficiency in cortisol, an essential hormone in regulating metabolism and stress response. 15 September 2017
A couple of the world’s largest pharma companies have been named and shamed for breaching the Code of Practice of the Association of British Pharmaceutical Industries (ABPI). 14 September 2017
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration on Thursday voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. 14 September 2017
Sandoz, the generic medicines unit of Swiss drug major Novartis, has released new data bolstering its case for regulatory approval for biosimilar adalimumab. 14 September 2017
The California State Assembly on Monday overwhelmingly approved Senate Bill 17, controversial legislation that could soon become the USA’s most comprehensive law aimed at shining a light on prescription drug prices, according to local media reports. 14 September 2017
FDA Commissioner Scott Gottlieb will take steps to ensure that the orphan drug designation is used appropriately, with new guidance to be issued on its application. 13 September 2017
US FDA Commissioner Scott Gottlieb says he supports the use of seamless trial design, a game-changing approach to drug development that does away with the long-standing three-phase standard of clinical testing. 13 September 2017
In recent years, nivolumab – which has been approved in Europe since June 2017 for adults with squamous cell carcinoma of the head and neck -has repeatedly been subject to early benefit assessments conducted by Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) for other oncological indications. 13 September 2017
Although the rate at which investigational drugs received marketing approval in the USA has declined in recent years, the cardiovascular approval rate trailed other drug approvals as a whole, while the time needed to develop cardiovascular drugs rose, according to a recently completed study conducted by the Tufts Center for the Study of Drug Development. 13 September 2017
The world’s best-selling drug has been approved by the European Commission in a new indication, offering a licensed biologic treatment option to a pediatric patient group that did not have one previously and is at risk of vision loss. 12 September 2017
The group representing generic and biosimilar drugmakers across Europe has published a new report reviewing the policies supporting the new wave of copycat treatments that could create access to biologics that are out of reach for many patients. 12 September 2017
With US approval expected to be granted within months for emicizumab, a monoclonal antibody currently under review for the prevention of bleeding in patients who have hemophilia A with factor VIII inhibitors, another question is looming large – how much is it worth? 12 September 2017
Privately-held USA-based Adello Biologics has had its Biologics License Application (BLA) for a biosimilar candidate referencing Neupogen (filgrastim) accepted for review by the US Food and Drug Administration (FDA). 12 September 2017
The US Food and Drug Administration has accepted a Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan (rituximab) from Sandoz. 12 September 2017
From December 1, 2017, approved suppliers will be required to enter a Compounder ID when submitting claims for eligible Australia’s Prescription Benefits Scheme (PBS) efficient funding of chemotherapy claims (EFC) items through PBS Online. Claims submitted without a compounder ID will not be paid, the country’s health regulator has announced. 11 September 2017
UK pharma major GlaxoSmithKline has announced that Menveo (meningococcal ACWY oligosaccharide conjugate vaccine) has received Therapeutics Goods Administration (TGA) approval for use in younger age groups in Australia. 11 September 2017
The Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMGMAN) has expressed optimism that the recent Executive Orders given by Vice President Yemi Osinbajo on the Support for Local Content in Public Procurement will lead to export of Nigerian medicines abroad, according to a report by Martins Ifjeh in This Day newspaper. 11 September 2017
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Xeljanz (tofacitinib) for some people with rheumatoid arthritis (RA). 8 September 2017
Biocon’s subsidiary in Malaysia, Biocon Sdn Bhd, has been issued a certificate of ´GMP Compliance´ for its insulins manufacturing facility by the HPRA (Ireland) as the representative European Union inspection authority. 8 September 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. 8 September 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