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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
The US Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose, developed by Ireland-based Adapt Pharma. 19 November 2015
Biotechnology
Expanded label for Vertex' Kalydeco approved in EUExpanded label for Vertex' Kalydeco approved in EU
The European Commission has approved expansion of the indication for Kalydeco (ivacaftor) from US biotech firm Vertex Pharmaceuticals. 19 November 2015
Pharmaceutical
Merck and Pfizer granted FDA Breakthrough Therapy designation for their avelumab in rare skin cancer
US drug giant Pfizer and German pharma company Merck have been granted Breakthrough Therapy designation by the US Food and Drug Administration for their avelumab in metastatic Merkel cell carcinoma. 19 November 2015
Generics
Following a public comment period, the Federal Trade Commission has approved a final order settling charges that the $8 billion merger between Endo International and privately-held Par Pharmaceuticals would likely be anticompetitive. 19 November 2015
Biosimilars
The European Generic and Biosimilar Medicines Association (EGA) and the Spanish Generic Medicines Association (AESEG) are joining forces to increase Spanish patients’ access to generic and biosimilar medicines, highlighting the importance of introducing measures that will increase access to high quality medicines and remove market barriers. 19 November 2015
Generics
The American Medical Association (AMA) has called for a ban on direct-to-consumer advertising of prescription drugs 18 November 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG), which last month had already found an added benefit of the drug for patients with advanced melanoma (The Pharma Letter October 20, now examined in another dossier assessment whether Bristol-Myers Squibb’s Opdivo (nivolumab) also offers an added benefit over the appropriate comparator therapy in the treatment of non-small cell lung cancer (NSCLC). 18 November 2015
Pharmaceutical
Jordon-headquartered Hikma Pharmaceuticals revealed today that it has received a letter from the US Food and Drug Administration closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal. 18 November 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) the medicines cost watchdog for England and Wales, has today published draft guidance that does not recommend Amgen’s Repatha (evolocumab) as an option for people with high cholesterol (primary hypercholesterolemia - heterozygous-familial and non-familial) and mixed dyslipidemia. 18 November 2015
Biosimilars
The US Food and Drug Administration has accepted the regulatory submission by Sandoz, the generics division of Novartis, for its biosimilar pegfilgrastim. 18 November 2015
Pharmaceutical
German pharma company Merck has expressed disappointment after the National Institute for Health and Care Excellence (NICE) failed to recommend two specific personalized treatments - cetuximab and panitumumab – for first line treatment in combination with chemotherapy of metastatic colorectal cancer 17 November 2015
Biotechnology
The European Medicines Agency has approved Xiapex (collagenase clostridium histolyticum) for the treatment of two Dupuytren’s contracture cords concurrently. 17 November 2015
Biotechnology
Regen BioPharmat announced that it has responded to question posed by the US Food and Drug Administration with regards to HemaXellerate. 17 November 2015
Biotechnology
Clovis Oncology yesterday revealed that, as a result of its regularly scheduled Mid-Cycle Communication Meeting held last week with the US Food and Drug Administration, there is likely to be a delay for its lead clinical candidate rociletinib. 17 November 2015
Biotechnology
Yesterday, the US Food and Drug Administration granted accelerated approval for US health care giant Johnson & Johnson subsidiary Janssen Biotech’s Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. 17 November 2015
Pharmaceutical
Although retained for use through the Cancer Drugs Fund, Swiss pharma giant Roche’s breast cancer combination treatment will not be recommended for routine National Health Service use in England because its price remains too high. 17 November 2015
Pharmaceutical
Japan’s Taiho Pharmaceutical has submitted an application for approval of the manufacture and marketing of TAC-202 (bilastine), an oral anti-allergy drug, to the Japanese Ministry of Health, Labor and Welfare. 16 November 2015
Pharmaceutical
There was some good news of Anglo-Swedish pharma major AstraZeneca on Friday, when, under the USA’s accelerated approval program, the Food and Drug Administration cleared for marketing its new cancer treatment Tagrisso (AZD9291). 14 November 2015
Biotechnology
US biotech firm Baxalta said on Friday that the US Food and Drug Administration has approved Adynovate [antihemophilic Factor (recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A. 14 November 2015
Pharmaceutical
CNS specialist Zambon and its partner, fellow Italy-based Newron Pharmaceuticals have announced that Switzerland’s regulator Swissmedic has approved Xadago (safinamide). 14 November 2015
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