Regulation
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Pharmaceutical
The US Food and Drug Administration has accepted the filing for review of brexiprazole for the treatment of schizophrenia and as an adjunctive therapy in the treatment of major depression. 24 September 2014
Biotechnology
Anglo-Swedish pharma major AstraZeneca’s global biologics R&D arm, MedImmune has received fast track designation from the US Food and Drug Administration for its investigational monoclonal antibody (MAb) MEDI3902 for the prevention of nosocomial pneumonia. 24 September 2014
Biotechnology
The US Food and Drug Administration has approved biotech major Celgene’s Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. 24 September 2014
Pharmaceutical
Shares of Tekmira Pharmaceuticals have rocketed after the US Food and Drug Administration authorized Tekmira to provide its investigational drug TKM-Ebola for treatment under expanded access protocols to people with confirmed or suspected Ebola virus infections. The company’s shares were up 12.8% to $22.74 yesterday on the news. 23 September 2014
Pharmaceutical
By the end of 2014, the Chilean pharmaceutical market is expected to be worth $2 billion, increasing at a compound annual growth rate (CAGR) of 11.3% over the next five years (to 2018). 23 September 2014
Pharmaceutical
Privately-held Swedish biopharmaceutical company OxThera AB’s product Oxabact (oxalobacter formigenes) has been granted orphan drug designation in the European Union for treatment of short bowel syndrome (SBS). 23 September 2014
Pharmaceutical
As the global market for drugs surpasses $1 trillion this year, growing payer scrutiny of value for money is just one of the factors that will drive disruptive change in the use of medicines over the next decade, according to a report issued today by the IMS Institute for Healthcare Informatics. 23 September 2014
Biotechnology
USA-based Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. 22 September 2014
Biotechnology
US biotech firm Halozyme Therapeutics says the US Food and Drug Administration has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase Ib/II clinical trial (S1313). 22 September 2014
Pharmaceutical
Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of chronic hepatitis C genotype 2 for Telavic (telaprevir) in Japan. 22 September 2014
Pharmaceutical
A new report from Escher, the independent TI Pharma platform for regulatory innovation, shows that the current regulatory system for medicines in the Europe Union could be used in more efficient and effective ways. 22 September 2014
Pharmaceutical
Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s Ministry of Health, Labor and Welfare for Eylea (aflibercept) Injection for myopic choroidal neovascularization (myopic CNV). 22 September 2014
Biotechnology
The European Commission has granted marketing authorization for US biotech major Gilead Sciences’ Zydelig (idelalisib) 150 mg tablets in the treatment of chronic lymphocytic leukemia and follicular lymphoma. 19 September 2014
Generics
US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined forces to introduce the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money. 19 September 2014
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application for Stendra (avanafil), developed by Vivus and marketed in the USA and Canada by Auxilium Pharmaceuticals. 19 September 2014
Biotechnology
US biotech company Navidea Biopharmaceuticals that its Lymphoseek (technetium Tc 99m tilmanocept) Injection has been granted Orphan Drug Designation by the US Food and Drug Administration for use in sentinel lymph node detection in patients with cancer of the head and neck. 19 September 2014
Pharmaceutical
An advisory panel of the US Food and Drug Administration has voted to tighten use of testosterone replacement drugs. 19 September 2014
Pharmaceutical
The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. 19 September 2014
Pharmaceutical
US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical development program for omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. 18 September 2014
Generics
The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened. 18 September 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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