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The UK government has committed to renegotiate its membership of the European Union and to giving the UK electorate the chance, in a referendum, to choose between the revised membership terms or “Brexit.” 17 March 2016
Pharmaceutical
Alleged failures to follow regulations by US pharma company Orexigen Therapeutics in its trial of obesity drug Contrave must not “become a trend,” former US Food and Drug Administration (FDA) deputy commissioner Joshua Sharfstein told The Pharma Letter. 17 March 2016
Pharmaceutical
The US Food and Drug Administration has approved Bayer's Kovaltry (octocog alfa; antihemophilic Factor [recombinant]), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. 17 March 2016
Biotechnology
Drugs cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending talimogene laherparepvec as an option for people with melanoma that has spread and can’t be surgically removed. 16 March 2016
Pharmaceutical
Stephen Ubl, president and chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), is optimistic that the association’s series of policy proposals can help to prompt a bright new period in drug discovery. 15 March 2016
Pharmaceutical
Allergan has received a Complete Response Letter from the US Food and Drug Administration for its Prior Approval Supplement for its Restasis (cyclosporine ophthalmic emulsion) container. 15 March 2016
Generics
A small notification by Indian drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has ensured that drug formulations under price control have risen to over 800, reports The Pharma Letter’s India correspondent. 15 March 2016
Biotechnology
The US Food and Drink Administration has granted Roche’s cancer immunotherapy atezolizumab (anti-PDL1; MPDL3280A) priority review for advanced bladder cancer. 15 March 2016
Pharmaceutical
Increases in anti-depressant usage by children have come about because of the decisions of the general practitioners (GPs) and other health professionals prescribing them, pharma companies have said. 15 March 2016
Biotechnology
KemPharm says that a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has been scheduled for May 5, to review its New Drug Application for KP201/APAP. 14 March 2016
Pharmaceutical
PTC Therapeutics says it intends to submit the results of the recently completed Phase III ACT DMD study for review by drugs regulatory Health Canada as part of the New Drug Submission (NDS) for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). 14 March 2016
Pharmaceutical
Following the AIDS crisis in the 1980s, the US FDA, in response to criticism of slow drug approvals, introduced the first of its expedited approval processes – Accelerated Approval, writes Dr Nicola Davies in her monthly exclusive article for The Pharma Letter. 14 March 2016
Biotechnology
The European Medicines Agency has, at the request of the European Commission, started a review of the cancer medicine Zydelig (idelalisib), following concerns over serious adverse events in ongoing clinical trials. 12 March 2016
Pharmaceutical
The US Food and Drug Administration on Friday approved pharma giant Pfizer’s Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. 12 March 2016
Generics
Pharma companies in China who wish to register chemical drugs in the country need to follow the new registration policy released by China’s Food and Drug Administration (CFDA) on March 4, effective immediately, reports The Pharma Letter’s local correspondent Wang Fangqing. 11 March 2016
Pharmaceutical
The pharma market in Poland will develop at the average annual growth rate of 4.8% between 2016 and 2021, according to a new report from Poland-based market research firm PMR. 11 March 2016
Biotechnology
Sarepta Therapeutics shares were up on Thursday, after the US Food and Drug Administration announced that the Peripheral and Central Nervous System Drugs Advisory Committee will hold a meeting on April 25, to review the company’s Duchenne muscular dystrophy (DMD) drug candidate eteplirsen. 11 March 2016
Generics
The European Commission has approved under the EU Merger Regulation the proposed acquisition of the generics business of Ireland-incorporated Allergan by Israel’s Teva Pharmaceutical Industries, subject to conditions. 10 March 2016
Biotechnology
AstraZeneca and its biologics R&D arm, MedImmune, have been granted Orphan drug designation by the US Food and Drug Administration for the investigational anti-CD19 monoclonal antibody, MEDI-551. 10 March 2016
Biotechnology
Shares of US biotech firm Medivation fell 2.48% to $38.16 yesterday, despite the company reporting positive news on the development of its blood cancer drug candidate. 10 March 2016
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
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