Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.
Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.
The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.
Freeman Technologies has signed a Canadian distribution deal for its powder flow analysis tech in a bid to win more QbD and PAT-focused Pharma customers.
Janssen says an alternative manufacturing approach will restore Doxil supplies, days after Ben Venue Laboratories’ (BVL) entered into consent decree with FDA.
GlaxoSmithKline has decided to only make once-monthly payments to suppliers, which could increase the amount of time it takes a CRO, CMO or other supplier to be paid for its work.
Impax Pharmaceuticals says it remains confident of resolving issues at its manufacturing facilities following the rejection of its Parkinson’s drug Rytary.
Almac says the completion of a Knowledge Transfer Partnership (KTP) has aided biocatalysis development offering clients an array of streamlined processes.
The Singapore Economic Development Board (SEDB) says it wants to nurture industry, academic and institutional alliances to attract further global investment in ‘Asia’s fastest growing bio-cluster.’
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
ADC Biotechnology has secured funding to take its cost-cutting antibody drug conjugate (ADC) tech to market and says pharma demand will drive partnerships and maybe even attract CMO takeover bids.
Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
The UK government’s health committee is calling for all clinical trial information to be in the public domain but industry push back is expected, experts say.
Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.
UK CMP Aesica has continued its strategy of partnering with academics with a new collaboration designed to make operations at its Cramlington plant more efficient.
BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs.
Cambridge Major Labs’ (CML) new private-equity investor plans to expand the CMO’s chemistry and API business and assess cross selling synergies with other firms in its portfolio.
The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
IDIFarma has been cleared to make commercial batches of high potency tablets and hopes the new capability will attract developers of niche drugs and large CMOs.
Exela Pharma Sciences will invest $8.5million in its research and manufacturing plant in North Carolina. The venture, to be spread over the next three years, will provide 38 new jobs almost doubling its present workforce.
Private equity group Warburg Pincus has acquired sterile injectables specialist JHP Pharmaceuticals for $195m and says it has a “sizable amount” to invest in the CMO.
Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.
The ability to predict which non-stick coating is best suited to a particular tablet production environment will save drugmakers time and money according to I Holland.
Last week, BASF officially opened a pharmaceutical grade omega-3 active pharmaceutical ingredient (API) facility on the Isle of Lewis, Scotland that it gained with the acquisition of Equateq earlier this year.
Merck Millipore hopes the promise of reducing the number of experiments needed during process development will win customers for its new MAb development kit.
Showa Denko KK (SDK) wants a share of the of the biopharmaceutical resins sector and has partnered with purification tech firm BIA Separations (BIASep) to get it.
