Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.
Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.
Aptar Pharma has acquired 20% of the US-based company, Kali Care, less than two months after inaugurating its first facility outside of France as it aims to expand globally.
Ibuprofen patch developer Medherant Ltd. has hired France-based contractor Laboratoires Plasto Santé (LPS) to make the product for clinical trials due to start this year.
Brineura's $702,000 (€640,000) a-year price tag reflects production costs and investment in tech used to administer the enzyme replacement therapy to the brain says BioMarin Pharmaceuticals.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.
Partnering and collaborating to advance drug delivery innovation is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.
Arecor has entered a £45m ($56m) agreement to develop once daily injection of Cadila Pharmaceuticals’ basal insulin product using its reformulation technology.
Ohr Pharmaceutical has raised enough money to complete a Phase III trial of its AMD drug - Squalamine – just days after NASDAQ officials gave it 180 days to regain the exchange’s minimum listing price.
Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.
The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.
Mylan has recalled batches of its EpiPen in the US over concerns the auto-injector device made by Pfizer’s Meridian Medical Technologies unit is faulty.
Alexion Pharmaceuticals will use the LNP delivery licensed from Arbutus Biopharma as part of its messenger RNA therapeutics development partnership with Moderna Therapeutics.
Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.
Heptares Therapeutics has entered into a drug discovery and licensing agreement with Daiichi Sankyo – providing further validation of the company’s structure-based drug design approach, says CEO.
The US FDA has told Scynexis not to start trials of an injectable formulation of its candidate antifungal Scy-078 after several volunteers developed blood clots during a Phase I study.
Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.
Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.
Titan Pharmaceuticals has put plans for a trial of its candidate Parkinson’s disease implant ropinirole after the US FDA asked for additional information.
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.
Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.
Rentschler Biotechnologie has added an antibody stabilising platform to its manufacturing services through a strategic alliance with formulation tech firm Leukocare.
Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.
Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.
Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience
Mithra Pharmaceuticals SA will seek US and EU approval for a rival to the NuvaRing contraceptive device in Q2, manufacturing the ring through its independent CDMO platform.
Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.
The Gates Foundation has invested $140m in Intarcia Therapeutics Inc to develop the biotech’s needle-free delivery pump for use with an HIV prophylactic therapy.
