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Pharmaceutical
The Russian National Parliament (State Duma) plans to impose a ban on the imports of unregistered drugs to Russia with the purpose of sales and making a profit in the country, according to the press-service of the Duma. 30 October 2014
Pharmaceutical
The US Food and Drug Administration yesterday granted accelerated approval for pharma major Pfizer’s Trumenba (meningococcal group B vaccine), the first vaccine licensed in the USA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. 30 October 2014
Pharmaceutical
The European Medicines Agency has given scientific advice to UK pharma major GlaxoSmithKline on its development plan for an Ebola vaccine. 29 October 2014
Biosimilars
The European Biosimilars Group – a sector group of the European Generic medicines Association, together with the Polish Generic Medicines Association organized a multi-stakeholder event in Warsaw this week gathering patient and hospital representatives, health economists, prescribers, industry delegates and research institutes to discuss the challenges and opportunities offered by biosimilar medicines. 29 October 2014
Pharmaceutical
Australian patients continue to pay less for medicines due to a notable rise in the number of prescriptions costing less than the Pharmaceutical Benefit Scheme (PBS) co-payment, according to a report released this week. 29 October 2014
Pharmaceutical
Netherlands-headquartered independent drugmaker Norgine says that its partner, Japan’s largest pharma company Takeda Pharmaceutical, has received approval in Russia for MoviPrep (2L polyethylene glycol + ascorbate) for bowel cleansing prior to any clinical procedures requiring a clean bowel. 28 October 2014
Pharmaceutical
Sarepta receives new FDA guidance on data needed for eteplirsen's NDA in Duchenne Muscular Dystrophy
Rare and infectious disease specialist Sarepta provided an update on its discussions with the US Food and Drug Administration regarding its planned New Drug Application submission for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy. 28 October 2014
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) posted third-quarter 2014 financial results today, showing that sales for the period fell 4% to $10.56 billion, shy of Wall Street expectations of $10.67 billion. 27 October 2014
Biotechnology
Biotechnology trade group EuropaBio has issued a new White Paper, aiming to identify the required adaptations in terms of science, drug and diagnostic development programs, as well as in terms of valuing and reimbursement that are essential in order to successfully integrate personalized medicine approaches in health care systems across Europe. 27 October 2014
Pharmaceutical
Jordanian drugmaker Hikma has seen its shares fall as a result of a warning from the US Food and Drug Administration relating to environmental monitoring at its Portugal plant. 27 October 2014
Pharmaceutical
Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application seeking approval of Carbella (carbamazepine) injection. 25 October 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization under exceptional circumstances for Scenesse (afamelanotide) for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP), a rare genetic disease which causes intolerance to light. 24 October 2014
Pharmaceutical
The European Medicines Agency has concluded its review of the benefits and risks of Iclusig (ponatinib), a treatment of leukemia, and has recommended strengthened warnings in the product information aimed at minimizing the risk of blood clots and blockages in the arteries. 24 October 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of Anglo-Swedish pharma major AstraZeneca’s Lynparza (olaparib). 24 October 2014
Pharmaceutical
The European Medicines Agency has completed its review of polymyxin-based medicines and issued its recommendations for safe use in patients with serious infections that are resistant to standard antibiotics. 24 October 2014
Pharmaceutical
The Australian government is to carry out a review of the regulation of medicines and medical devices. 24 October 2014
Pharmaceutical
Privately-held Switzerland-headquartered Ferring Pharmaceuticals says its Cortiment (budesonide) treatment for the induction of remission in patients with active, mild to moderate ulcerative colitis has received marketing approval from 27 European Union member states following the EU Mutual Recognition Procedure. 23 October 2014
Biosimilars
Results from a survey of 470 European physicians conducted by the Alliance for Safe Biologic Medicines (ASBM) set the stage for a stakeholder meeting at the Italian Ministry of Health to discuss the future of biosimilars policy in Italy. 23 October 2014
Pharmaceutical
During the past months, the European Medicines Agency has put in place a system to give the best possible scientific advice to companies that are currently developing possible vaccines and/or treatments to fight Ebola virus disease. 23 October 2014
Pharmaceutical
The Australian Department of Health has confirmed that growth of the Pharmaceutical Benefits Scheme cost was negligible for the financial year 2013-2014. 23 October 2014
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
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