Regulation
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Pharmaceutical
Swedish Orphan Biovitrum together with its Australian partner, the local subsidiary of Italy’s Menarini, received marketing authorization in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA). 21 August 2015
Biosimilars
Pharma trade group Medicines Australia has expressed strong concerns about the recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) that pharmacists be allowed to substitute the biosimilars in place of biologic medicines prescribed by a patient’s doctor. 21 August 2015
Pharmaceutical
Health Canada has granted Bristol-Myers Squibb’s Daklinza (daclatasvir) approval for the treatment of chronic hepatitis C infection. 20 August 2015
Pharmaceutical
Following evaluation of dossiers relating to CNS specialist Zambon and its partner, fellow Italy-based Newron Pharmaceuticals’ Parkinson’s disease drug Xadago (safinamide), the German Institute for Quality and Efficiency in Health Care (IQWiG) concluded that an added benefit cannot be derived versus comparator drugs from the dossier, because relevant study data were not considered and the analyses were therefore incomplete. 20 August 2015
Pharmaceutical
Swiss specialty pharma company Santhera Pharmaceuticals has received a rare pediatric disease designation from the US Food and Drug Administration for it drug idebenone for the treatment of Duchenne muscular dystrophy. 20 August 2015
Pharmaceutical
The new “female viagra” will be pulled from the market within years, according to the founder and senior adviser of Public Citizen’s Health Research Group, Sidney Wolfe. 20 August 2015
Pharmaceutical
Swiss drug major Novartis has received approval from the European Commission for Odomzo (sonidegib) for the treatment of locally advanced basal cell carcinoma (laBCC) in adult patients who are not amenable to curative surgery or radiation therapy. 20 August 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for an update to the European label for Boehringer Ingelheim’s Giotrif (afatinib), strengthening and broadening the efficacy profile based on additional Phase III data. 20 August 2015
Pharmaceutical
Indian drugmaker Sun Pharmaceutical Industries yesterday announced that the US Food and Drug Administration has approved its supplemental New Drug Application (sNDA) for Ximino (minocycline HCl) extended-release capsules. 20 August 2015
Biosimilars
Hospira announced it has registered its biosimilar Inflectra (infliximab) to treat inflammatory conditions in Australia. 20 August 2015
Pharmaceutical
With interest in personalized medicines growing, drug and diagnostics companies are investing in the development of companion diagnostics that can show that their use in conjunction with personalized therapeutics will lead to positive health outcomes. 20 August 2015
Pharmaceutical
Despite a slight drop in the number of US Food and Drug Administration drug approvals during first-half 2015, treatments for cancer remain an important component of pharmaceutical companies' R&D pipelines, according to a new Fitch Ratings report. 20 August 2015
Pharmaceutical
United Therapeutics has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of fellow USA-based AbbVie. 19 August 2015
Biotechnology
US biotech company Amgen has reached an agreement to pay $71 million to 48 US states and the District of Columbia over the marketing of Enbrel (etanercept) and Aranesp (darbepoetin alfa). 19 August 2015
Pharmaceutical
The US Food and Drug Administration has approved the first drug to treat sexual desire disorder in women, Addyi (flibanserin) from Sprout Pharmaceuticals. 19 August 2015
Generics
The International Generic Drug Regulators Pilot (IGDRP) was launched in April 2012 in the face of mounting pressures that confront generic drug review programs worldwide and a willingness on the part of regulatory agencies to pursue collaboration and convergence to help mitigate these pressures. 19 August 2015
Biotechnology
In Mexico, there have been concerns among the public about the fact that the Trans-Pacific Partnership (TPP) negotiations have largely been shrouded in secrecy, while the introduction of biotechnological drugs to the Mexican market has become a flashpoint, reports the China state news agency Xinhua. 19 August 2015
Generics
The US Food and Drug Administration has warned Netherlands-incorporated generic drugmaker Mylan that three of its pharmaceutical manufacturing facilities in India have been identified as having significant violations of current Good Manufacturing Practice (cGMP) regulations 19 August 2015
Pharmaceutical
According to a guideline issued by China’s State Council on August 18, China aims to set up a more scientific and efficient system to ensure the safety and quality of medicines and medical instruments that come into the market, by reforming its appraisal and approval system for such products. 19 August 2015
Pharmaceutical
USA-based clinical research spending has dropped 32% in the first year-on-year comparison since Open Payments data started to be collected in the USA. 19 August 2015
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
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
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