The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Antengene, Arcturus, Atara, Ayala, Bioniz, BMS, Forge, Inozyme, Matinas, Opko, Passage, Pfizer, Provention.
A new rule intended to give drug manufacturers the flexibility they need to enter into value-based purchasing agreements with state Medicaid programs and commercial payers could end up hurting patients at the pharmacy counter in the U.S.
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Immunicum.
Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
Osmotica Pharmaceuticals plc’s amendment earlier this month to the NDA for arbaclofen in spasticity resulting from multiple sclerosis wasn’t enough to quell the concerns of the FDA, which smacked the firm with its second complete response letter (CRL).
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