Regulation
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Generics
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that Netherlands-incorporated drugmaker Mylan’s $7.2 billion acquisition of Swedish drugmaker Meda would likely be anticompetitive. 9 September 2016
Pharmaceutical
In draft guidance issued today, the National Institute for Health and Care Excellence (NICE) is recommending Zepatier (elbasvir-grazoprevir) as an option to treat certain types of hepatitis C. 9 September 2016
Generics
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
Pharmaceutical
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health, noted the European Medicines agency on a website posting. 8 September 2016
Biotechnology
Japanese drugmaker Ono Pharmaceutical has taken two steps forward in strengthening its oncology presence in Japan by gaining a new approval for Opdivo (nivolumab) and launching Kyprolis (carfilzomib). 8 September 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list a new treatment for HIV, dolutegravir (Tivicay) and to amend the listing of a currently-funded HIV treatment, abacavir sulphate with lamivudine (Kivexa). 8 September 2016
Biotechnology
The US Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) from pharma giant Merck & Co for Keytruda (pembrolizumab). 7 September 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to SAGE-547 for the treatment of postpartum depression (PPD) from US clinical-stage biotech Sage Therapeutics. 7 September 2016
Pharmaceutical
In India, the mandatory marketing code for pharma companies would be having strong penal provisions in order to prevent bribing of doctors for prescribing drugs by drug companies. 7 September 2016
Pharmaceutical
The European Commission has approved Orencia (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. 6 September 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today issued final draft guidance, repeating its negative view on Swiss pharma giant Roche’s Cotellic (cobimetinib) with vemurafenib (Zelboraf, also from Roche) for a type of advanced skin cancer. 5 September 2016
Biotechnology
The Food and Drug Administration's Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]). 5 September 2016
Pharmaceutical
Novo Nordisk announced on Friday that the US Food and Drug Administration has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec (Tresiba) and liraglutide (Victoza) in adults with type 2 diabetes. 5 September 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which suggests that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven (eribulin) versus established comparator therapies - as defined by the Federal Joint Committee (G-BA) - for the treatment of unresectable advanced or metastatic liposarcomas. 5 September 2016
Biotechnology
In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether patients treated for multiple myeloma with the monoclonal antibody Empliciti (elotuzumab) in combination with lenalidomide (Revlimid) and dexamethasone who have received one previous treatment benefit from this new combination. 3 September 2016
Biotechnology
The US Food and Drug Administration has granted Fast Track designation for biotech major Biogen’s aducanumab, its investigational treatment for early Alzheimer’s disease (AD). 2 September 2016
Pharmaceutical
Novo Nordisk says that the European Commission has approved the expanded use of Xultophy. 2 September 2016
Biotechnology
The US Food and Drug Administration has approved biotech major Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). 2 September 2016
Pharmaceutical
The National Institute for Health and Care Excellence has today issued draft final guidance recommending German pharma major Bayer’s Xofigo (radium-223 dichloride) as an option for treating prostate cancer, reversing an earlier decision not to back the drug. 2 September 2016
Pharmaceutical
Canada is experiencing a growing number of opioid overdoses and deaths across the country, and days such as the International Overdose Awareness Day are bringing needed attention to this crisis. 1 September 2016
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
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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