Delivery formulations

Oncology vaccine ensured 100% survival rate in lab studies

18-Sep-2018 By Maggie Lynch

Scientists demonstrated that an adjuvant to an immunotherapy vaccine resulted in a 100% survival rate in mice with aggressive melanoma.

‘Revamped’ MannKind secures $105m licensing deal, plans Afrezza expansion

17-Sep-2018 By Flora Southey

MannKind Corporation, of Afrezza fame, and United Therapeutics have signed an exclusive licensing and collaboration agreement for dry powder pulmonary hypertension products.

US FDA approves Sun Pharma’s Cequa to treat dry eye disease

12-Sep-2018 By Maggie Lynch

The FDA has approved Sun Pharma’s Cequa for the treatment of dry eye disease.

Microbubble technology bypasses blood brain barrier, says researcher

11-Sep-2018 By Maggie Lynch

A study at Washington University in St. Louis has shown a new way to deliver drugs to the brainstem in a non-invasive administration: microbubbles and ultrasound.

Novartis sheds oral solid generics in $900m Aurobindo deal

10-Sep-2018 By Flora Southey

In Novartis’ latest restructuring move for 2018, the pharma giant announced plans to sell US generic oral solids and dermatology businesses to Aurobindo Pharma US.

Blue clay could help combat superbug threat, say researchers

03-Sep-2018 By Flora Southey

Scientists are investigating the effectiveness of Oregon blue clay in killing disease-causing bacteria, including antimicrobial-resistant superbugs.

Boehringer begins construction at €85m tablet manufacture plant

29-Aug-2018 By Ben Hargreaves

Boehringer Ingelheim has begun construction of a new production facility for drugs in tablet form, with an expected completion date of 2020.

China dismisses top officials over sub-par vaccines

22-Aug-2018 By Ben Hargreaves

A number of officials related to the Changsheng Biotechnology vaccine scandal have been relieved of their positions by China’s government.

Nebraska obtained lethal injection from unauthorised source, says Fresenius Group

22-Aug-2018 By Flora Southey

The State of Nebraska has carried out an execution using drugs procured from an illegitimate source, claims Fresenius Kabi.

Novo Nordisk looks to ‘eliminate hypoglycaemia’ with $800m insulin deal

21-Aug-2018 By Ben Hargreaves

Novo Nordisk has acquired Ziylo to gain access to a glucose responsive insulin platform it says could help eliminate hypoglycaemic episodes.

Merck KGaA challenges you to €10k small molecule competition

13-Aug-2018 By Flora Southey

Merck KGaA is celebrating its 350th birthday with a competition aimed at identifying the best synthetic route for a small molecule in 96 hours.

Frequency sounds out progenitor cell activation for hearing restoration

09-Aug-2018 By Maggie Lynch

Frequency Therapeutics initiates a Phase I/II clinical trial for hearing restoration, using progenitor cell activator technology for the first time in adult patients.

Sun Pharma reveals sprinkling of good news, launches novel drug product

07-Aug-2018 By Ben Hargreaves

Sun Pharma has announced that its Kapspargo Sprinkle product, an extended-release heart drug, has been launched in the US market.

US FDA declines Pain Therapeutics’ opioid drug for the fourth time

07-Aug-2018 By Maggie Lynch

FDA declines the approval of Pain Therapeutics abuse-deterrent opioid treatment for the fourth time.

Pfizer plans to invest $5bn across the US, begins with $465m facility

26-Jul-2018 By Ben Hargreaves

Pfizer has revealed it will invest $5bn to support operations in the US, with the first step being the construction of a 400,000-square-foot production facility, costing $465m.

Cambrex enters finished dosage market with $425m Halo Pharma acquisition

23-Jul-2018 By Flora Southey

API maker Cambrex Corporation will add drug development and finished dosage capabilities to its network with the acquisition of CDMO Halo Pharma.

3D printing brings novel doses, shapes and characteristics to ‘advanced manufacturing’, states Aprecia

19-Jul-2018 By Ben Hargreaves

The US FDA has drawn industry attention to the potential of 3D printing and continuous manufacturing, which it says could “improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the US”.

AcuraStem targets small molecule ALS market

11-Jul-2018 By Flora Southey

AcuraStem has received $3.7m to develop a small molecule treatment for amyotrophic lateral sclerosis (ALS), which it says could compete with Sanofi’s Riluzole and Mitsubishi Tanabe’s Radicava.

Two US patents will help deliver ketamine-like antidepressant effects, says VistaGen

11-Jul-2018 By Flora Southey

The US Patent and Trademark Office (USPTO) has granted two patents related to VistaGen Therapeutics’ lead asset AV-101, an oral candidate designed to treat CNS diseases and disorders.

Elite Pharma: Eyes on Troxyca, but Pfizer blocking generic release

11-Jul-2018 By Flora Southey

Pfizer’s decision to discontinue abuse-deterrent Troxyca ER is “effectively stopping us from entering the market,” says Elite CEO.

Significant step taken towards insulin pill

28-Jun-2018 By Ben Hargreaves

Researchers from Harvard University have developed an insulin formulation using two ionic liquids they say could lead to the development of a pill for diabetics.

US FDA rejects Valeant’s Duobrii for plaque psoriasis

19-Jun-2018 By Flora Southey

The US FDA has rejected Valeant Pharmaceutical International’s investigational topical treatment for plaque psoriasis, Duobrii.

Back to the future? The resurgence of combination drug products

19-Jun-2018 By Flora Southey

Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.

FDA advisory committee prep: ‘Work hard on Q&A – that’s where you’ll win it,’ says consultant

19-Jun-2018 By Flora Southey

Providing a coherent and persuasive risk assessment and a “well-messaged outline of key communication points” are key to winning US FDA Advisory Committee approval, say industry consultants.

Flex Pharma to cut two trials, reduce headcount and explore merger options

14-Jun-2018 By Flora Southey

Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).

After raising $85m, SutroVax contracts Lonza to support vaccine development

12-Jun-2018 By Melissa Fassbender

Lonza is supporting SutroVax’s development of its pneumococcal conjugate vaccine candidate through an end-to-end supply relationship.

Smallpox treatment nears FDA approval after years of development, collaboration

11-Jun-2018 By Melissa Fassbender

SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.

UK initiative targets rapid production of thermally-stable vaccines

07-Jun-2018 By Nick Taylor

The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.

Motif Bio secures £10m to support antibiotic commercialization efforts

17-May-2018 By Melissa Fassbender

Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.

INTERPHEX 2018

Excipient makers want to be the ‘first second’ in novel ingredient development, say execs

17-May-2018 By Flora Southey

An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.

AstraZeneca offloads off-patent drug to focus on ‘main therapy areas’

09-May-2018 By Melissa Fassbender

In a deal worth up to $538m, AstraZeneca has entered into an agreement with Luye Pharma Group for the sale and license of the rights to Seroquel and Seroquel XR in several markets.

FDA approves simultaneous administration of Tafinlar, Mekinist for ATC

08-May-2018 By Brittany Farb Gruber

Novartis has received approval for the administration of Tafinlar and Mekinist together for the treatment of anaplastic thyroid cancer (ATC).

AuroMedics recalls antibiotics due to ‘particulate matter’ in product

07-May-2018 By Melissa Fassbender

AuroMedics Pharma LLC is voluntarily recalling two lots of injectable antibiotics following customer complaints of “red particulate matter” in the product.

INTERPHEX 2018

The future of the small molecule? Increased complexity and biologic pairings, says industry

01-May-2018 By Flora Southey

Next-generation regenerative and personalised medicines may be attracting increased industry attention, but small molecule drugs are here to stay, say executives.

Formulations for sale: Noramco and SPI Pharma target drugmakers with scalable tech

26-Apr-2018 By Flora Southey

Noramco and SPI Pharma have partnered to offer ‘ready-to-implement’ formulations for branded and generic drugmakers.

Mayne Pharma opens $80m facility, expands CDMO offering

19-Apr-2018 By Melissa Fassbender

Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.

Biopharma’s increasing demand for complex kit assembly drives Almac expansion

18-Apr-2018 By Melissa Fassbender

Almac Group has expanded its commercial packaging capabilities to meet a “significant increase” in demand for complex kit assembly as biopharma brings more advanced sterile and biological products to the market, says CDMO.

GSK offloads gene therapy portfolio and takes stake in Orchard

12-Apr-2018 By Dan Stanton

GlaxoSmithKline has sold a number of gene therapy products – including its approved autologous ex vivo product Strimvelis – to Orchard Therapeutics.

Stellar ups aquaculture on demand for limpet protein used in vaccine production

11-Apr-2018 By Dan Stanton

Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.

DCAT WEEK

Pharma 'endangered,' though 'huge opportunities' exist as the industry evolves

10-Apr-2018 By Melissa Fassbender

Pharma must look outward to innovate and find new areas of growth, as research and development productivity and returns on innovation continue to decline, says industry expert.

CMO for Pfizer ADHD drug hit with US FDA warning

10-Apr-2018 By Dan Stanton

The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.

Novartis upping presence in gene therapies through $8.7bn AveXis buy

10-Apr-2018 By Staff Reporter

Novartis will add an AAV9 gene delivery platform and manufacturing facility through the $8.7bn (€7bn) acquisition of AveXis.

Ferring looks to gain microbiome drug approval with Rebiotix buy

09-Apr-2018 By Staff Reporter

Ferring Pharmaceuticals is buying Rebiotix and says its lead candidate has the potential to be the first human microbiome product approved anywhere in the world.

Lilly to develop encapsulated diabetes cell therapies through Sigilon deal

05-Apr-2018 By Flora Southey

Eli Lilly has licensed Sigilon Therapeutics’ technology to develop encapsulated cell therapies for the treatment of type 1 diabetes.

Twist Bioscience secures $50m to advance DNA Synthesis Platform

03-Apr-2018 By Melissa Fassbender

The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.

Consortium looks to make bacteria for anti-inflammatory drug delivery to the gut

29-Mar-2018 By Dan Stanton

Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.

Medpharm targeting increased growth through PE investment

27-Mar-2018 By Staff Reporter

Ampersand Capital Partners has invested in drug delivery technology firm MedPharm.

Alembic receives FDA 483, but no repeat observations nor data issues

22-Mar-2018 By Staff Reporter

Alembic Pharmaceuticals has received a US FDA Form 483 with three observations at a finished formulation plant in Gujarat, India.

Lundbeck to buy Prexton in potential $1bn+ deal

19-Mar-2018 By Staff Reporter

The Danish drugmaker says it will take responsibility for commercial manufacturing after acquiring Parkinson’s disease candidate foliglurax in a deal worth up to €905m ($1.1bn).