A nonprofit plans to address drug shortages in the U.S. by making its own products under a model that seeks to break a chain of manufacturing quality and price concerns that also have the sharp attention of regulators and policymakers.
Taiwan's JHL Biotech said its listing of an unspecified number of shares on the Taiwan Emerging Stock Board this week has clocked in a value of NTD$1.89 billion ($57.6 million) as it ramps up services in the manufacture and development of biologics in Asia ahead of a potential main board listing.
India may house drug testing laboratories in each state under an INR17.5 billion ($270 million) plan to shore up quality.
India wants to cap drug prices at home while ramping up sales of generics to Western markets targeting the U.S.--all while dozens of manufacturing plants are under regulatory scanners on quality and testing.
India's Biocon has moved to buy a manufacturing plant from Acacia Lifesciences, the firm said in an announcement to the Mumbai stock exchange, taking over the domestic maker of active pharmaceutical ingredients and advanced intermediates this month.
Expectations that the U.S. FDA is ready to take a harder look at products from China, mirroring efforts seen in India in the past few years, has brought the shortage of inspection manpower for drug manufacturing in China into sharper focus.
Médecins Sans Frontières warned in a high-profile campaign during the United Nations summit on development in in New York that the United States is pressuring Indian Prime Minister Narendra Modi to change the country's intellectual property policies for drugs, which could result in millions of people around the world being unable to access medicines.
A rope-a-dope strategy of sorts on biosimilars is in play for India's Dr. Reddy's as it shifts from a strategy of racing to the domestic market with products in favor of a coiled approach that will let it strike out in several markets in a burst.
Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.
The research arm of Sun Pharmaceutical Industries has seen its license for epilepsy drug Elepsia XR revoked by the U.S. FDA because of manufacturing violations at its production site, dealing a blow to its aims of moving beyond generics.