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Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard that has their top picks for upside potential in the biotech segment for 2015. 5 December 2014
Biotechnology
The US Food and Drug Administration yesterday approved a new use for Incyte Corp’s Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition. 5 December 2014
Generics
The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances where brand-name drug companies refuse to sell to prospective Abbreviated New Drug Application (ANDA) sponsors supplies of reference listed drugs (RLDs). 4 December 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Danish CNS specialist Lundbeck’s Selincro (nalmefene) offers an added benefit over the appropriate comparator therapy for people with alcohol dependence, drawing a negative conclusion. 4 December 2014
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there is no evidence that Fluad flu vaccine from Swiss drug major Novartis has caused serious events including deaths in Italy. 4 December 2014
Biotechnology
Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto (blinatumomab), an immunotherapy from USA-based Amgen, to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. 4 December 2014
Pharmaceutical
Japanese pharma major Astellas Pharma has received European Commission approval for a variation to amend the Marketing Authorization for Xtandi (enzalutamide). 3 December 2014
Pharmaceutical
Swiss biotech firm Actelion has submitted a centralized Marketing Authorization Application to the European Medicines Agency for selexipag (trade name Uptravi) in the treatment of pulmonary arterial hypertension (PAH). 3 December 2014
Biotechnology
Puma Biotechnology will delay the filing of its New Drug Application (NDA) for the approval of PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Its shares dropped 24% on the news yesterday. 3 December 2014
Pharmaceutical
French pharma major Sanofi says that the US Food and Drug Administration has approved Priftin (rifapentine), in combination with isoniazid (INH), for a new indication for the treatment of latent tuberculosis infection (LTBI) in patients aged two years and older at high risk of progression to TB disease. 3 December 2014
Pharmaceutical
The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib) from Anglo-Swedish drug major AstraZeneca. 2 December 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has reversed its decision on Gazyvaro (obinutuzumab), manufactured by Swiss drug major Roche. 2 December 2014
Pharmaceutical
The Italian Medicines Agency (AIFA) has suspended two batches of Swiss drug major Novartis’ Fluad seasonal flu vaccine following 13 deaths in regions across Italy of elderly patients taking the drug. 1 December 2014
Pharmaceutical
In Denmark, new rules took effect on Saturday, November 1 to ensure greater transparency about relations between pharma and medtech companies on the one hand and health care professionals on the other. 1 December 2014
Pharmaceutical
US health care giant Johnson & Johnson’s Belgium-based subsidiary Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency to vary the marketing authorization for Imbruvica (ibrutinib), to include a new therapeutic indication for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 1 December 2014
Pharmaceutical
French drugmaker Ipsen says that the US Food and Drug Administration has accepted for review its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients. 28 November 2014
Pharmaceutical
The European Commission has granted EU marketing authorization for German family-owned pharma major Boehringer Ingelheim’s Vargatef (nintedanib), valid for the 28 countries within the European Union. 28 November 2014
Pharmaceutical
Swiss drug major Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted accelerated assessment to LCZ696, an investigational medicine for patients with heart failure with reduced ejection fraction (HFrEF). 28 November 2014
Biotechnology
The UK National Institute for Health and Care Excellence (NICE) has today issued final draft guidance recommending US drugmaker Alexion Pharmaceuticals’ Soliris (eculizumab) for funding for treating atypical hemolytic uremic syndrome (aHUS. 27 November 2014
Pharmaceutical
The Association of the British Pharmaceutical Industry has published new research showing that UK use of branded medicines is less per person than many other countries, with the UK remaining ninth out of 13 countries surveyed. 27 November 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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