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Breaking News on Global Pharmaceutical Technology & Manufacturing

Compounding firm looks at NDA opportunity for reformulation of Mallinckrodt's H.P. Acthar

23-Mar-2017 - 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.

Pulmatrix secures EU patent for dry powder delivery tech

22-Mar-2017 - Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.

update - Epipen manufacturer Meridian Medical Technologies completes investigation

Meda recalls EpiPen batch in Denmark after reports of defects

20-Mar-2017 - Mylan subsidiary Meda has recalled a batch of EpiPens in Denmark after reports some have defective auto-injectors.

Cannabinoid-based chewing gum enrolls patients in Ph II trial

16-Mar-2017 - Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.

Heptares, Daiichi Sankyo to develop small molecules for pain treatment

15-Mar-2017 - 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.

US FDA orders Scynexis not to start new trials of injectable antifungal

13-Mar-2017 - 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.

Vaxess granted $6m to develop sustained release vaccine patches

07-Mar-2017 - 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.

Nemus hires Catalent to formulate second chemo-induced nausea drug

06-Mar-2017 - Catalent Pharma Solutions has been hired to formulate Nemus Bioscience’s synthetic cannabinoid based chemotherapy induced nausea drug.

Turmeric bioavailability enhancer could be used with APIs, Wacker

02-Mar-2017 - 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.

Baxter and ScinoPharm sign injectable oncology drug strategic alliance

01-Mar-2017 - Up to 20 injectable cancer drugs will be made at facilities in Taiwan and Germany under terms of a partnership between Baxter and Scinopharm.

Titan puts Parkinson's disease implant trial on hold after FDA asks for more data

28-Feb-2017 - 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. shuts sustained release tech lab

23-Feb-2017 - 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 raises cash for Ph II trial of Sickle Cell drug in EU, Middle East and Caribbean

22-Feb-2017 - 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.

Tilray grows capacity in North America's only GMP cannabis facility

16-Feb-2017 - 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.

Workers strike at Merck injectable drug plant in Goa, India over wages

09-Feb-2017 - Workers at a Merck KGaA injectable drug and soft gel capsules plant in Goa, India have gone on strike over a wages dispute.

Rentschler: Stabilisation tech sparks 'paradigm shift' for bio-formulation services

02-Feb-2017 - Rentschler Biotechnologie has added an antibody stabilising platform to its manufacturing services through a strategic alliance with formulation tech firm Leukocare.

Ferring licenses Enteris Peptelligence to turn injectable into oral drug

30-Jan-2017 - Ferring is the third company in a week which will use Enteris BioPharma’s Peptelligence engineering platform for small molecules to develop oral formulations.

Beximco forms manufacturing JV with Malaysia's BioCare

30-Jan-2017 - Beximco Pharmaceuticals Limited has partnered with BioCare Manufacturing Sdn Bhd to make generic drugs for the Malaysian market.

Lundbeck banks on shark antibody delivery tech to cross blood-brain barrier

27-Jan-2017 - 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

Sanofi and Nordic Bioscience deals ‘validate’ oral delivery tech, Enteris

25-Jan-2017 - Enteris Biopharma has secured two deals in as many days to use its excipient-based platform to enhance delivery of preclinical peptide candidates.

Belgian CDMO to launch generic of vaginal contraceptive device NuvaRing

24-Jan-2017 - 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 has resubmitted Dextenza to US FDA after CRL

23-Jan-2017 - 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.

News in brief

Cipla targets South African asthma market with breath activated inhaler

19-Jan-2017 - Cipla has launched a breath activated inhaler in South Africa.

MannKind ‘aggressively’ moving forward with inhalable epinephrine

16-Jan-2017 - 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 to assess resveratrol formulation across softgel platforms

11-Jan-2017 - Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.

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