- Novartis has revealed plans to spin off its existing generics and biosimilars division, Sandoz, into a standalone company. The core company wants to turn Sandoz into an autonomous business so that it can focus on patented “innovative” medicines, with plans to finalize the spin-off in H2 of 2023.
- Janssen-Cilag has discontinued sales of Rybrevant (amivantamab) in Germany following a rating from the Federal Joint Committee of Germany (G-BA), in which the group said that the added benefit of the drug is “not proven” for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with activating EGFR-Exon 20 insertion mutations. In a written statement to Navlin, a spokesperson for Janssen explained that throughout the process the company worked “closely with the authorities” and confirmed that it will “continue to collaborate with them further to highlight the importance of real-world evidence and single-arm data.”
- The World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) has recommended Valneva’s COVID-19 vaccine, VLA2001, for people aged 18 to 50 years old. According to WHO, SAGE has thoroughly assessed the data on the quality, safety, and efficacy of the vaccine for people aged 18 to 50 years old
Moderna announced it is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court of the District of Massachusetts and the Regional Court of Dusseldorf, Germany. The company stated: “Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This ground-breaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty.”
The Health Sciences Authority (HSA) of Singapore has authorized expanded use of Moderna’s COVID-19 vaccine, Spikevax, via the Pandemic Special Access Route (PSAR) to include those aged six months to 17 years.
The World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) has recommended Valneva’s COVID-19 vaccine, VLA2001, for people aged 18 to 50 years old. According to WHO, SAGE has thoroughly assessed the data on the quality, safety, and efficacy of the vaccine for people aged 18 to 50 years old.
Canada’s government is purchasing an additional 4.5 million doses of Moderna’s Omicron-adapted bivalent vaccine booster candidate, an agreement that hinges on regulatory approval of the new vaccine booster by Health Canada.
Pfizer has tapped Shanghai-based Huahai Pharmaceutical to manufacture its oral COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) in China. The non-exclusive production and supply agreement was signed between Huahai and Pfizer’s China subsidiary and will last for five years.
The National Medical Products Administration (NMPA) of China has approved Ascletis Pharma’s Investigational New Drug (IND) application for ASC10, an oral inhibitor candidate targeting RdRP for COVID-19, announced the company.
Ukraine has received 100,000 doses of Janssen’s COVID-19 vaccine, Jcovden, which was acquired through the COVAX Facility, announced the World Health Organization (WHO).
Australia’s ATAGI has recommended Novavax’s Nuvaxovid for use in adolescents aged 12-17 years after TGA provisionally approved the COVID-19 vaccine last month.
Moderna finalized its submission to the U.S. Food and Drug Administration (FDA) seeking emergency use authorization for its bivalent COVID-19 booster vaccine targeting the BA.4 and BA.5 Omicron sub-variants.
Japan’s Ministry of Heath, Labour, and Welfare (MHLW) has now officially confirmed that it will be holding the first meeting of its new drug pricing and distribution committee on August 31.
The Department of Health of Aged Care of Australia has published its updated National Medicines Policy (NMP) and is seeking feedback until September 27, 2022. The NMP’s 4 key pillars include timely, equitable and reliable access to medicines and medicines-related services, at a cost that individuals and the community can afford; medicines meet the required standards of quality, safety, and efficacy; quality use of medicines and medicines safety; and responsive, innovative, and sustainable medicines industry and research sectors with the capability, capacity, and expertise to respond to current and future health needs.
Argentina has enacted the Antimicrobial Resistance Prevention and Control Law (Law 27680), following Senate approval earlier in August. The law creates the National Commission for the Control of Antimicrobial Resistance (CONACRA), a technical advisory body to provide recommendations on strategies to promote prevention and control of AMR to the Ministry of Health.
Argentina’s Minister of Health Carla Vizzotti has convened with representatives of the health portfolio, other state officials and representatives of the pharmaceutical industry to assure compliance with the July 2022 agreement to stall medicine prices at an increase of only up to 1 point below the general Consumer Price Index (CPI) from June 2022.
The Ministry of Food and Drug Safety (MFDS) has implemented the Prompt Reflection (Unification Adjustment) Plan for Validity Permits today, August 26, 2022. The plan oversees how to make sure changes to originator drugs are reflected for all respective generic drugs.
The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 45 formulations under the Drugs (Prices Control) Order, 2013, based on the decision of the 100th Authority meeting. The list of drugs that are fixed by NPPA includes various strengths of the anti-diabetes drug Sitagliptin combination and Linagliptin.
The Indian Pharmacopoeia Commission (IPC) has added five new Indian Pharmacopoeia Reference Standards (IPRS) and seven new impurity reference substances to Indian Pharmacopoeia (IP) 2022.
The Pakistan Health Ministry has rejected the Drug Regulatory Authority of Pakistan’s (DRAP) summary to increase the prices of 40 medicines, English daily The Nation reports.
The Guild Health Insurance Fund (IKK) has proposed three measures for the sustainable financing of statutory health insurance (GKV) in response to the recently passed “Financial Stabilisation of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) bill.
Merck’s Pifeltro (doravirine) has received a favorable opinion for reimbursement by the High Health Authority (HAS) of France for the treatment of patients aged 12 to 18 years old weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
The High Health Authority (HAS) of France has granted early access to Enhertu (trastuzumab deruxtecan) for the treatment of stomach cancer.
The Federal Joint Committee (G-BA) of Germany has assigned off-label expert groups to assess sorafenib (Bayer’s Nexavar) and abiraterone (Janssen’s Zytiga) in new indications.
The REvalMed SNS Coordinating Group (CG) has finished working on Therapeutic Positioning Reports (TPRs) for six drugs that recently gained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and has initiated assessments on eight new therapies that all recently gained CHMP approval.
The National Institute for Health and Care Excellence (NICE) has recommended Tecentriq (atezolizumab) for use within the Cancer Drugs Fund (CDF) for patients with early-stage non-small-cell lung cancer, whose tumors express the PD-L1 mutation.
Price & Reimbursement
Janssen has discontinued sales of Rybrevant (amivantamab) in Germany following a rating from the Federal Joint Committee of Germany (G-BA), in which the group said that the added benefit of the drug is “not proven” for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with activating EGFR-Exon 20 insertion mutations.
The Swiss Federal Government has announced plans to procure 40,000 doses of a vaccine against monkeypox, as well as 500 units of SIGA’s tecovirimat amid the ongoing monkeypox outbreak in Switzerland.
The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin’s Roctavian (valoctocogene roxaparvovec), the company’s gene therapy for the treatment of severe haemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and detectable antibodies to adeno-associated virus serotype 5 (AAV5).
Bavarian Nordic announced it has struck a deal with the Pan American Health Organization (PAHO) to enable equitable access to its monkeypox vaccine, Jynneos, in Latin America and the Caribbean.
According to a local media source, Dawn, an ongoing conflict between Pakistan’s drug regulators and pharmaceutical manufacturers, has led to a shortage of over 40 drugs in the country.
Novartis’ Zolgensma (onasemnogene abeparvovec) and Roche’s Evrysdi (risdiplam) will be included in Poland’s September reimbursement list for the treatment of spinal muscular atrophy (SMA).
Biogen’s Spinraza’s (nusinersen) will be available to spinal muscular atrophy (SMA) patients through health insurance in the Czech Republic.
The National Medical Products Administration (NMPA) of China has authorized Fosun Kite to initiate a clinical trial of Yescarta (axicabtagene ciloleucel) in adults with large B-cell lymphoma (LBCL) that is refractory to first-line immunochemotherapy or who have relapsed within 12 months of first-line immunochemotherapy.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicine (PIM) designation to Savara’s molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
AstraZeneca announced that it has received approval from the Japan Ministry of Health, Labor, and Welfare (MHLW) for Lynparza (olaparib), Tagrisso (osimertinib), and Ultomiris (ravulizumab).
Health Canada has approved Bristol Myers Squibb’s (BMS) Opdivo (nivolumab), in combination with platinum-doublet chemotherapy, for adult patients with resectable (tumours ≥4 cm or node-positive) non-small-cell lung cancer (NSCLC) in the neoadjuvant setting, announced the company.
The European Commission (EC) has granted conditional marketing authorization (CMA) to Janssen’s Tecvayli (teclistamab) for the treatment of relapsed and refractory multiple myeloma (RRMM).
The Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has accepted BeiGene’s supplemental Biologics License Application (sBLA) for tislelizumab, in combination with chemotherapy, as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
The Indonesia National Agency for Drug and Food Control (BPOM) has approved Takeda’s dengue vaccine, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) for the prevention of dengue disease caused by any serotype in individuals from six to 45 years of age.
The Drugs Controller General of India (DCGI) has approved AstraZeneca’s Lynparza (olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high-risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy.
Gilead Sciences Sunlenca (lenacapavir) injection and tablets have been granted Marketing Authorization by the European Commission for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Novartis has revealed plans to spin off its existing generics and biosimilars division, Sandoz, into a standalone company. The core company wants to turn Sandoz into an autonomous business so that it can focus on patented “innovative” medicines, with plans to finalize the spin-off in H2 of 2023.
The World Health Organization (WHO) has granted pre-qualification to Kenyan drug manufacturer Universal Corporation (UCL) for the production of sulfadoxine/pyrimethamine (SP), to prevent malaria in pregnant women and infants in Africa.
The UK will begin offering eligible patients smaller monkeypox vaccine doses in a pilot scheme to address the issue of the short supply of Bavarian Nordic’s Imvanex (Live Modified Vaccinia Virus Ankara).
Zelluna Immunotherapy has received investment from Takeda to advance its T-Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer.
A team of researchers from Oxford University has initiated a new clinical trial dubbed PLATINUM – placebo-controlled randomized trial of tecovirimat in non-hospitalized monkeypox patients – in the UK, to test Tpoxx (tecovirimat), an antiviral that has the potential to treat Monkeypox.
The European Medicines Agency (EMA) has published a list of critical medicines for use for the Monkeypox public health emergency (PHE) under Regulation (EU) 2022/123, which provides the European Medicines Agency with a framework to monitor and mitigate potential and actual shortages of centrally and nationally authorized medicinal products considered “critical” in an emergency.
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