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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 BeOne Medicines, formerly 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 (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
China Food and Drug Administration’s (CFDA) Minister Bi Jingquan and Bill & Melinda Gates Foundation co-chairman Bill Gates recently officially signed the Memorandum of Understanding on Strategic Cooperation between the CFDA of the People's Republic of China and the Gates Foundation. 13 June 2016
Pharmaceutical
By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. 12 June 2016
Pharmaceutical
The European Ombudsman, Emily O'Reilly, has welcomed increased transparency in the clinical testing of Humira (adalimumab), one of the world’s biggest selling drugs, following her inquiry into the publication of clinical study reports. 10 June 2016
Pharmaceutical
The Indian Pharmacopeia Commission (IPC) has released the national reference standards, specifically referred as the Indian Pharmacopoeia Reference Substances (IPRS Vaccines), the first such initiative to be undertaken of its kind. 9 June 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency, PHARMAC, today announced funding of six new treatments across important areas of health, including major advancements in the treatment of hepatitis C. 9 June 2016
Biotechnology
Trade group AusBiotech said today it has provided a submission in response to the Australin Productivity Commission’s Intellectual Property (IP) Arrangements Draft Report, disagreeing with numerous recommendations in regard to patents and data protection. 9 June 2016
Biosimilars
Doctors are split on whether they feel currently confident handing out biosimilars to patients, according to a global survey. 9 June 2016
Generics
There is an urgent need for renewal of Written Confirmation (WCs) issued by the Drug Controller General of India (DCGI) for active pharmaceutical ingredient (API) exporters to the European Union, according to Brand India Pharma. 9 June 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has today published provisional guidance, within its Appraisal Consultation Document, on aflibercept (Eylea). 8 June 2016
Pharmaceutical
The European Commission has approved the use of Swiss pharma giant Roche’s Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with epidermal growth Factor Receptor (EGFR)-activating mutations. 8 June 2016
Pharmaceutical
US Food and Drug Administration advisory panels yesterday voted 14 to three to recommend approval of Vantrela ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 8 June 2016
Pharmaceutical
US-based Adamis Pharmaceuticals (Nasdaq: ADMS) has suffered a share-busting setback in its New Drug Application (NDA) for its epinephrine injection pre-filled single dose syringe (PFS) product for emergency treatment of acute anaphylaxis, a severe allergic reaction. 7 June 2016
Biotechnology
US RNA-based drug developer Sarepta Therapeutics says that the US Food and Drug Administration has requested additional data relating to its regulatory approval for its much delayed Duchenne muscular dystrophy drug candidate. 7 June 2016
Biotechnology
Privately-held Swiss biotech Novimmune has announced that its lead program, NI-0501, has been declared eligible for the PRIME (PRIority MEdicine) scheme of the European Medicines Agency (EMA) for the treatment of primary hemophagocytic lymphohistiocytosis (HLH). 6 June 2016
Pharmaceutical
The US Food and Drug Administration has approved marketing of a new fixed-dose combination of two FDA-approved blood pressure lowering agents. 6 June 2016
Pharmaceutical
The progress that has been made globally in developing treatments for rare diseases in the last 20 years is enormous. At the end of the 20th century there were just eight medicines approved in Europe for diseases compared to around 200 today. But there is still a long way to go. 6 June 2016
Pharmaceutical
Plucky US microcap Celator Pharmaceuticals has rewarded its investors this morning with a 70% stock price rise after agreeing to a $1.5 billion all-cash takeout offer from Jazz Pharmaceuticals over the holiday weekend. 5 June 2016
Generics
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 2016
Pharmaceutical
German Institute for Quality and Efficiency in Health Care’s (IQWiG) re-assessment of Roche’s Cotellic has come out more favorably. 3 June 2016
Biotechnology
Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval. 3 June 2016
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