Proposed biosimilar accepted for review by EMA
The EMA has accepted Prestige BioPharma’s marketing application for its trastuzumab biosimilar.
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Heritage announces product recall after sterility test failure
Heritage has recalled two of its injectable treatments after microbial growths were found.
Shingles vaccine approved for use in China
GlaxoSmithKline (GSK) has been given Chinese approval for its shingles vaccine.
WHO announces support for drug pricing transparency
Member countries of WHO have agreed to support pricing transparency for medicines, vaccines and other health products.
API markets to grow 6.8 percent by 2026
Global active pharmaceutical ingredients market set to surpass US$274.9 billion by 2026.
Proteomics research advanced by use of AI
Researchers succeed in using machine learning to make the mass analysis of proteins faster and almost error-free.
British Columbia first province to switch patients to biosimilars
British Columbia has said it will switch as many as 20,400 patients from three branded biologic drugs to cheap biosimilars.
CPhI China opens with analysis pointing to a surge in growth in 2019
Regulatory reforms and harmonisation reported as key drivers of industry in China.
BPOG extractables testing of AdvantaPure®’s key silicone and TPE tubing products complete
Test results help drug manufacturers compare tubing.
FDA approves first gene therapy for paediatric spinal muscular atrophy
The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).
$85 million settlement agreed for opioid case in Oklahoma
Teva has agreed to pay Oklahoma, resolving allegations that illegal marketing of its medication contributed to the state’s opioid epidemic.
First PI3K inhibitor for breast cancer approved by FDA
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
LABVOLUTION: Paving the way for the lab of the future
The connected laboratory is now the only way forward, as the three days of the LABVOLUTION show have clearly demonstrated. Decision-makers, product developers and users from the various segments of the laboratory industry gathered in Hannover for a close look at the latest developments and future trends.
Retail prices on several anti-cancer medications slashed
The retail prices of some anti-cancer drugs have been cut by 87 percent by the drug price control authority in India.
FDA sends warning letter to Canadian OTC manufacturer
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
