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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration on Friday approved US drugmaker Vanda Pharmaceutical's Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. 3 February 2014
Pharmaceutical
The US Food and Drug Administration said on Friday that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. 3 February 2014
Generics
US specialty health care firm Endo Health Solutions and its takeover target generic drugmaker Boca Pharmacal have agreed to a settlement resolving US Federal Trade Commission charges that Endo’s $225 million cash acquisition of Boca would be anticompetitive (The Pharma Letter August 29, 2013). 2 February 2014
Pharmaceutical
US drugmaker Avanir Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration for approval of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. 30 January 2014
Generics
US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee, is leading a group of Senate and House Republican lawmakers in sending a letter to Food and Drug Administration Commissioner Margaret Hamburg expressing concerns about the FDA’s proposed regulation to allow generic drug companies to unilaterally change their drug labeling information, saying “such a rule would conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers.” 30 January 2014
Pharmaceutical
Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved its supplemental New Drug Application for three-times-a-week Copaxone (glatiramer acetate) 40mg/mL, a new dose of its best-selling multiple sclerosis drug. 29 January 2014
Pharmaceutical
China's National Health and Family Planning Commission this week issued a draft regulation on health workers' professional conduct, reports the state Xinhua news agency. 29 January 2014
Pharmaceutical
Though Chinese regulators are pushing ahead with a blacklisting system to combat bribery in pharmaceutical procurement, enforcement problems have undermined similar initiatives in the past, according to Policy and Regulatory Report (PaRR). 29 January 2014
Pharmaceutical
The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available data support the efficacy and safety of US pharma giant Merck & Co’s Ragwitek. 28 January 2014
Pharmaceutical
US specialty pharma group Heron Therapeutics saw its shares plunge after the company revealed an around one-quarter delay to its timeline for the resubmission of the New Drug Application for Sustol, a long-acting formulation of granisetron, to the US Food and Drug Administration for chemotherapy-induced nausea and vomiting (CINV). 28 January 2014
Pharmaceutical
UK drugs watchdog the National Institute of Health and Care Excellence (NICE) has issued new draft guidance recommending approval of Japanese drug major Astellas Pharma’s Xtandi (enzalutamide) as an option for treating hormone relapsed metastatic prostate cancer in adults on the National Health Service. 28 January 2014
Pharmaceutical
The European Commission has granted marketing authorization to extend the use of Esmya (ulipristal acetate) tablets to up to two courses of three-month treatment of uterine fibroids, said the drug’s producer, Hungary’s largest drugmaker Gedeon Richter. 27 January 2014
Biotechnology
US biotech firm Northwest Biotherapeutics has entered into a set of agreements for large-scale expansion of the manufacturing, storage, handling and distribution of its DCVax-L and DCVax-Direct products, with the company's long-time contract manufacturer, Cognate Bioservices. 27 January 2014
Generics
“It is vital that costs associated with regulatory processes do not become a barrier to developing and improving generic and biosimilar products or even maintaining the product in the market,” stated Beata Stepniewska, deputy director general of the European Generic Medicines Association (EGA) at the 13th EGA Regulatory & Scientific Affairs Conference, held in London on January 23-24. 27 January 2014
Pharmaceutical
Considered a global clinical trial hub three years ago, India has suffered a series of setbacks, with its apex court, the Supreme Court in early 2013 revoking the Ministry of Health’s right to clear clinical trials in the country, reports The Pharma Letter’s Indian correspondent. 27 January 2014
Pharmaceutical
Among a batch of positive opinions issued today by the European Medicines Agency’ s Committee for Medicinal Products for Human Use (CHMP), there was good news for UK pharma giant GlaxoSmithKline relating to Eperzan (albiglutide). 24 January 2014
article
There were a number of positive, and negative, opinions issued on January 24, following the monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; see also separate stories for GlaxoSmithKline and Novartis). 24 January 2014
Pharmaceutical
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given Swiss drug major Novartis (NOVN: VX) a positive opinion for the use of Xolair (omalizumab). 24 January 2014
Pharmaceutical
The recently launched Breakthrough Therapy Designation (BTD) program in the USA, aimed at expediting development and review of drugs intended to treat a serious condition, has the potential to shorten development time considerably, according to the Tufts Center for the Study of Drug Development, which recently completed an assessment of the BTD program. 24 January 2014
Generics
As if the Indian drug major has not had enough negative news from the US regulator, the US Food and Drug Administration yesterday notified Ranbaxy Laboratories that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. 24 January 2014
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