Drug delivery, formulation

Oncology trends: smaller indications and greater efficiency, says QuintilesIMS Institute

12-Jun-2017 By Melissa Fassbender

As pharma targets smaller indications and becomes more efficient, oncology clinical trial duration – and patient enrollment – have decreased.

'Easy to work with' tops CRO benchmarking report

05-Jun-2017 By Melissa Fassbender

With or without a preferred provider – what do pharma sponsors look for in a contract research organization?

Rho to support NDA for Evoke Pharma’s patented nasal spray

01-Jun-2017 By Melissa Fassbender

Rho has been contracted to support Evoke Pharma’s planned NDA submission for its nasal delivery formulation of metoclopramide, Gimoti.

Cambrex continues to up capacity with more than $200m invested in 5 years

31-May-2017 By Melissa Fassbender

Cambrex Corporation has increased new capacity at its Sweden-based cGMP as the manufacturer focuses on market demand and customer need, says VP.

People on the move

Outsourcing-Pharma's Hiring and Firing Roundup May '17

31-May-2017 By Melissa Fassbender

This month’s roundup includes new executive leadership teams, hires on both sides of the Atlantic for CRO Smithers Viscient, a new VP and medical director at Clinipace, among others.

Pharma finance

The changing landscape of the CRO industry

30-May-2017 By Jason Monteleone, Guest contributor

How we classify CROs has seemingly changed overnight.

Charles River partners with CRO to expand PDX model capabilities

22-May-2017 By Melissa Fassbender

Charles River Laboratories International, Inc. has partnered with OcellO to expand its PDX model capabilities and has made several additions to its online Tumor Model Compendium.

Sanofi’s €250m AI-driven R&D collaboration for metabolic disease

15-May-2017 By Flora Southey

Sanofi and Artificial Intelligence (AI)-driven Exscientia have announced a €250m ($271.9m) drug target research collaboration and licence option agreement. 

Aptar Pharma continues its North American expansion

11-May-2017 By Melissa Fassbender

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. 

NIH award emphasizes long-term relationship, says AMRI

02-May-2017 By Melissa Fassbender

AMRI has received a 5-year federal contract award from the National Institutes of Health (NIH) under which it will provide drug substance development and manufacturing services.

Solubility solutions: Catalent increases spray drying capacity at Pharmatek

27-Apr-2017 By Melissa Fassbender

Catalent Pharma Solutions is increasing cGMP spray drying capacity at its Pharmatek facility in response to industry demand for improved solubility.

Covance ups BioPharmCMC capabilities in UK

25-Apr-2017 By Melissa Fassbender

Covance is expanding into new laboratories in York, England as it anticipates continued growth into 2018.

How to accelerate clinical trials during an epidemic

20-Apr-2017 By Melissa Fassbender

Randomized controlled trials are the fastest way to identify vaccines in an outbreak, but more collaboration is needed among international researchers – including CROs.

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 By Gareth Macdonald

Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

Partnering key to deliver next-gen drug delivery tech, say industry experts

19-Apr-2017 By Melissa Fassbender

Partnering and collaborating to advance drug delivery innovation is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.

Cross-industry partnership looks to accelerate drug discovery through data sharing

13-Apr-2017 By Melissa Fassbender

BioCelerate has partnered with Accenture to develop a platform that will aggregate and analyze preclinical and clinical information to "drive additional industry value."

Novel in vitro approach bypasses in vivo bioequivalence studies

06-Apr-2017 By Melissa Fassbender

Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.

US FDA accepts Evoke's CMC and PK trial plan for nasal metoclopramide

05-Apr-2017 By Gareth Macdonald

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.

Pfizer CentreOne: service expansions one step in fulfilling pledge to grow capabilities

28-Mar-2017 By Melissa Fassbender

Pfizer CentreOne has recently expanded its fill-finish and highly potent solid oral dose service offerings at two of its contract manufacturing facilities as it aims to fulfill a promise to grow its capabilities.

Axim taps CRO for cannabinoid product development and clinical trials

23-Mar-2017 By Melissa Fassbender

Axim Biotech has contracted an ophthalmology CRO to support upcoming product development and clinical trials for its cannabinoid-based therapeutics.

CROs form strategic alliance to provide end-to-end services

20-Mar-2017 By Melissa Fassbender

The strategic alliance between Metrion and Concept will provide clients with a fully integrated ion channel drug discovery service.

Cannabinoid-based chewing gum enrolls patients in Ph II trial

16-Mar-2017 By Melissa Fassbender

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 By Melissa Fassbender

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.

Nemus hires Catalent to formulate second chemo-induced nausea drug

06-Mar-2017 By Gareth Macdonald

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

PEOPLE ON THE MOVE

Outsourcing-Pharma's Hiring and Firing Roundup February '17

28-Feb-2017 By Dani Bancroft

Outsourcing-Pharma presents this month's roundup of who is moving where in the contract research and manufacturing industry.

Evotec taps into Oxford innovation through £13m grant scheme

22-Feb-2017 By Dani Bancroft

Dubbed LAB282, the £13m (€15M) Oxford University drug discovery program with Evotec has announced two grant winners and a second set of awards of up to £250,000.

Charles River splits off and divests CDMO business

16-Feb-2017 By Dani Bancroft

Charles River Laboratories International Inc. has sold off its CDMO business QS Pharma LLC, saying the small-molecule manufacturing business was “not optimized” within the firm's portfolio.

Is the return of the one-stop-shop model just a CMO marketing ploy?

16-Feb-2017 By Dan Stanton

End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.

CDMO Rentschler looks to highlight importance of drug formulation

06-Feb-2017 By Melissa Fassbender

Rentschler Biotechnologie has announced a strategic alliance with Leukocare through which the CDMO hopes to emphasize drug formulation as a “key success factor” in drug development.

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 By Dan Stanton

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 By Dani Bancroft

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.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

18-Jan-2017 By Dani Bancroft

AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS). 

Catalent to assess resveratrol formulation across softgel platforms

11-Jan-2017 By Dan Stanton

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

Orchard picks PharmaCell to make its autologous cell therapies

09-Jan-2017 By Dan Stanton

Orchard Therapeutics has selected Dutch CMO PharmaCell to manufacture products from its gene therapy pipeline.

IntelGenx announces multiple commercialization agreements with Chemo Group in 2017

05-Jan-2017 By Melissa Fassbender

IntelGenx Corp has granted Chemo Group an exclusive worldwide license to commercialize several products – moving the company into the novel drug delivery market.

Intarcia receives $140m Gates Foundation grant for needle-free HIV tech

04-Jan-2017 By Dani Bancroft

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.

Growth in biologics and vaccines leading injectables business, Aptar Pharma

12-Dec-2016 By Melissa Fassbender

Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.

Lonza confirms interest in Capsugel takeover

12-Dec-2016 By Gareth Macdonald

Lonza has confirmed it is interested in buying Capsugel. 

Needle-free Zika vaccine shows promise in clinical trial

07-Dec-2016 By Melissa Fassbender

As part of its collaboration with the National Institutes of Health (NIH) in the DNA vaccine clinical trial for the Zika virus, PharmaJet is providing its Stratis Needle-Free device and training to the NIH.

Catalent adding OTC capsule maker Accucaps to global softgel network

28-Nov-2016 By Dan Stanton

Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.

Swallowing Stars: MIT spin-out invents gastric device which solves problem of daily dosing

22-Nov-2016 By Dani Bancroft

Lyndra Inc. has developed a star shaped gastric device which claims to solve the problem of delivering drugs with short half-lives.

MIT’s Langer sells off excipients biotech to break into Biosimilar market

21-Nov-2016 By Dani Bancroft

Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.

Primate deaths cause stock plummet for Arrowhead as RNAi PhII trials halted by FDA

18-Nov-2016 By Dani Bancroft

The US FDA has halted a trial of a candidate Hepatitis B infection drug developed by Arrowhead Pharma Inc. after primate deaths in a toxicology study.

Product recall after mechanism failure complaints

Teleflex recalls faulty nasal delivery devices used to administer opioid overdose meds

10-Nov-2016 By Dani Bancroft

Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".

Slovakian CDMO Saneca ups capabilities after controlled release contract win

10-Nov-2016 By Staff Reporter

Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.

Envigo testing single wall carbon nanotubes

27-Oct-2016 By Melissa Fassbender

Envigo has collaborated with InterTek and OCSiAl to develop TUBALL™ single wall carbon nanotubes, which is the first of its kind to complete REACH registration.

IDT Biologika to provide live virus filling and finishing services to BARDA

25-Oct-2016 By Melissa Fassbender

IDT Biologika has been awarded a five-year contract to provide live virus filling and finishing services in a deal worth up to $50m.

PPD to support biologics, inhalation products at expanded lab

21-Oct-2016 By Melissa Fassbender

PPD has added 4,300 square feet of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices to the company’s Athlone, Ireland-based GMP facility.

Is industry consolidation stifling pharma innovation?

12-Oct-2016 By Melissa Fassbender

In a year of “merger mania,” researchers suggest the elimination of competition is reducing innovation in the pharmaceutical industry.

Smart injector allows for in-home injections

10-Oct-2016 By Melissa Fassbender

QuiO has raised $1.05m to develop its real-time adherence monitoring solution for injectable therapies – a device which could allow CROs to monitor injection events remotely.