Delivery formulations

Upperton upping spray-dry production in $2m relocation

15-Mar-2018 By Staff Reporter

Spray-drying service provider Upperton Pharma Solutions has expaned to offer GMP manufacturing for early-stage clinical trials.

‘Limited competition’ for Pfizer generic drives launch rejig

13-Mar-2018 By Flora Southey

A lack of generic competition for Pfizer’s contraceptive Depo-Provera has influenced Amphastar’s decision to prioritise its pre-filled syringe version, says executive.

What to expect at DCAT Week 2018

13-Mar-2018 By Melissa Fassbender

This year’s DCAT Week will focus on innovation in the pharmaceutical industry, with two new Executive Insights programs.

New method to predict drug stability a boon for pharma

13-Mar-2018 By Melissa Fassbender

A new method to predict the physical stability of drug candidates is attracting interest from pharmaceutical companies who could use the technology to de-risk early development.

News in Brief

Clariant raising colouring costs

12-Mar-2018 By Staff Reporter

Clariant will raise the prices across its Masterbatch range by up to 7% from April.

Teva terminates pain drug development with Xenon

08-Mar-2018 By Dan Stanton

Xenon Pharmaceuticals will regain the full rights to TV-45070 after the topical analgesic failed to meet endpoints in a Phase II trial last year.

No chewing, grinding or snorting: Recipharm adds Altus anti-abuse tech

06-Mar-2018 By Dan Stanton

A license agreement will allow Recipharm to offer its customers Altus Formulation’s INTELLITAB and FLEXITAB anti-abuse drug delivery technologies.

WuXi STA to make oligonucleotides for Regulus

01-Mar-2018 By Staff Reporter

Regulus Therapeutics has entered into an oligonucleotide synthesis collaboration with STA Pharmaceuticals for research and mid-scale non-GMP/cGMP manufacturing.

Fujifilm building $37m facility to support liposome drugs

27-Feb-2018 By Dan Stanton

Toyama Chemical’s facility will support trials of lipsome drugs produced using technologies cultured through Fujifilm’s photographic film business.

Lonza ups HPAPI encapsulation capacity in Florida

22-Feb-2018 By Staff Reporter

Lonza has increased its encapsulation capacity and invested in highly potent active pharmaceutical ingredient (HPAPI) services at a facility in Tampa, Florida.

West Pharma to merge manufacturing and exit sites in network shake-up

21-Feb-2018 By Flora Southey

A network reshuffle will see West Pharma consolidate manufacturing and close some facilities to “streamline” its plant network.

Takeda looks to oligonucleotides in $230m CNS collaboration

21-Feb-2018 By Staff Reporter

Takeda Pharmaceuticals will work with Wave Life Sciences to develop nucleic acid therapies for central nervous system disorders, including Huntington’s and Lou Gehrig’s disease.

Pfizer consumer health sale: Reckitt Benckiser plays down rumours

21-Feb-2018 By Dan Stanton

Reckitt Benckiser Group says it will be disciplined in its M&A strategy but remains silent on speculation it is buying Pfizer’s consumer healthcare business.

USV receives FDA close-out at Indian plant

20-Feb-2018 By Staff Reporter

The US FDA has lifted a warning at an Indian oral solid dose manufacturing facility run by USV Private Limited.

Slippery when wet: Colorcon coating aims to ease tablet swallowing

20-Feb-2018 By Dan Stanton

Colorcon has created a coating system it says makes swallowing tablets easier, fulfilling patient compliance demands in recent regulatory guidance.

ImmunoGen closing MA plant: 20 jobs to go, $20m in savings

15-Feb-2018 By Staff Reporter

ImmunoGen says it is shifting drug conjugate manufacturing and quality testing to an outsourcing model and will close its Norwood facility.

Generics, mergers and Teva’s woes: Agilent talks pharma opportunities

15-Feb-2018 By Dan Stanton

Agilent Technologies says changes in the industry this year will present opportunities for continued growth in its pharma processing equipment and consumables business.

Short-acting to extended half-life, Ireland signs exclusive haemophilia deal

14-Feb-2018 By Flora Southey

The Republic of Ireland will move its population from short-acting to extended half-life haemophilia therapies, under an exclusive two-year deal with Sobi.

Nordic project takes ‘manufacturing-on-demand’ approach to future drugs

07-Feb-2018 By Dan Stanton

Nordic Universities will investigate 3D printing, electrospraying, and microfluidics in an industry supported collaboration aimed at revolutionising production in an age of personalised medicine.

Vical cuts staff, ditches candidate to ‘conserve capital’

01-Feb-2018 By Flora Southey

Vical has dismissed 40 employees and abandoned a Phase III vaccine candidate in a reshuffle it says allows for greater resources on HSV-2 and antifungal trials.

Lonza: Capsugel contributes to ‘record year’ for Swiss CDMO

01-Feb-2018 By Dan Stanton

Lonza has attributed a record-breaking year to the addition of Capsugel along with continued high pharma and biotech demand.

Intas puts the fizz back into ex-Sanofi plant with generic effervescents

31-Jan-2018 By Flora Southey

Intas Pharmaceuticals says it ‘worked hard’ over two years to bring an ex-Sanofi manufacturing facility back into production in Newcastle, UK.

Hovione adds inhalation product development tech at former Generis site

30-Jan-2018 By Staff Reporter

Hovione has bolstered its encapsulation for inhaled products technology capabilities at its site in Portugal.

Analgesics and beyond: Time-release delivery firm looks for investment

25-Jan-2018 By Dan Stanton

InSitu Biologics says it is looking for investors to support its hydrogel-based drug delivery system AnestaGel.

Shortages and soaring generic prices prompt US hospitals to form not-for-profit drug business

25-Jan-2018 By Flora Southey

Drug shortages and rising medicine prices in the US have driven a group of hospitals to form a not-for-profit generic drug manufacturing firm.

Braeburn’s subdermal opioid addiction candidate receives CRL from FDA

24-Jan-2018 By Dan Stanton

The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).

Benchmark for tracking industry efforts to fight antimicrobial resistance launched at WEF in Davos

23-Jan-2018 By Gareth Macdonald

The Access to Medicines Foundation has launched a ‘benchmark’ that maps drug industry efforts to stem the spread of drug resistance at the World Economic Forum in Davos, Switzerland.

news in brief

MedPharm launches new topical formulation testing technologies

15-Jan-2018 By Staff reporter

MedPharm has launched automated testing systems for topical formulations it claims can help developers cut timelines.

Aviragen Vaxart merger to create $264m tablet vaccine firm

15-Jan-2018 By Dan Stanton

Aviragen Therapeutics has called on shareholders to back its proposed merger with oral vaccine delivery firm Vaxart.

Eisai ups capacity for Alzheimer’s disease pills and PPIs in China

11-Jan-2018 By Gareth Macdonald

Eisai Co Ltd has completed construction of an oral solid dose form manufacturing facility in Suzhou, China.

Recipharm to pay INR2.8bn for remaining stake in injectables firm Nitin Lifesciences

02-Jan-2018 By Gareth Macdonald

Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.

US FDA OKs removal of safety warning on GSK's combo asthma drugs

21-Dec-2017 By Gareth Macdonald

The US FDA has cleared GSK to remove the box warning from its combination asthma drugs Breo Ellipta, Advair diskus and Advair HFA after safety data.

3D-printing on trend: Aprecia and Cycle sign orphan drug deal

14-Dec-2017 By Flora Southey

Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.

Arrowhead turns to TRiM tech to drive clinical pipeline and collaboration

14-Dec-2017 By Dan Stanton

Arrowhead Pharmaceuticals says it is looking to move six candidates into the clinic within the next year thanks to its newly unveiled RNAi delivery platform.

CMOs lacking GMP land snail-based OTC maker US FDA warning

14-Dec-2017 By Dan Stanton

Failing to ensure third-party manufacturers operated in conformance with GMP has landed Korean OTC maker Seindni Co. Ltd a US FDA warning.

US FDA looks to answer industry's 3D printed drug concerns

12-Dec-2017 By Dan Stanton

3D printing offers “a tantalizing step toward changing the manufacturing processes” for personalised medicines says a US FDA scientist.

Emergent eyes capacity boost for anti-nerve gas auto-injector

11-Dec-2017 By Dan Stanton

Emergent BioSolutions says it is looking to expand auto-injector manufacturing capacity due to growing demand for its nerve agent antidote product Trobigard.

US approves Ozempic, Novo Nordisk says EU and Japan up next

07-Dec-2017 By Flora Southey

Novo Nordisk’s once-weekly diabetes treatment Ozempic has been given the US FDA green light, and the firm said it expects approval in Europe and Japan early 2018.

GW prepping for mid-2018 CBD epilepsy candidate approval in US

05-Dec-2017 By Dan Stanton

Cannabinoid firm GW Pharmaceuticals says it is “inspection ready” as it prepares for potential US approval of its epilepsy candidate Epidiolex (cannabidiol or CBD).

Once-a-month opioid: Injectable Sublocade wins US approval

04-Dec-2017 By Flora Southey

The US FDA has approved Indivior’s once-monthly, injectable buprenorphine formulation to treat moderate to severe opioid use disorder.

Almac looking to move into sterile injectables in the long-term

29-Nov-2017 By Flora Southey

Almac will “eventually” move into sterile injectables says executive Brian Eastwood, adding the market has good potential for growth in the contract manufacturing space.

Korea development: Celltrion prepping to enter US generics market

28-Nov-2017 By Dan Stanton

Celltrion Pharm has received an FDA facility inspection in Korea ahead of a first venture into the US generics market.

News in Brief

US FDA inspection lands Glenmark with 483 with seven observations

28-Nov-2017 By Dan Stanton

Glenmark has received a US FDA Form 483 with seven observations at its Baddi finished formulations facility in Baddi, India.

US FDA approves drug duo pill for HIV

22-Nov-2017 By Flora Southey

The US Food and Drug Administration has approved ViiV Healthcare’s two-drug treatment for HIV-1 maintenance, the first time the drugs have been combined into a single pill.

Pfizer demands return of drugs set for use in US lethal injections

21-Nov-2017 By Dan Stanton

The Big Pharma firm says it strongly objects to its products being used for capital punishment and has asked 31 states to return drugs.

Researchers tweak opioid compounds to combat overdose

20-Nov-2017 By Flora Southey

Scientists have developed opioid pain relievers that do not slow or stop breathing – the cause of opiate overdose – they say could reduce the risk of accidental death.

Corium close to partnering on transdermal Alzheimer’s drug

20-Nov-2017 By Dan Stanton

Corium says it is in talks with commercialisation partners for its transdermal Alzheimer’s disease candisate Corplex Donepezil ahead of a potential 2019 launch.

AbbVie claims strike did not stop operations at Irish plant

15-Nov-2017 By Dan Stanton

Trade union members picketed AbbVie’s bulk tablet facility in Cork yesterday but the firm says operations and supply have not been disrupted.

Old drugs, new tricks: Rejuvenating antibiotics can overcome resistance, says Helperby

15-Nov-2017 By Flora Southey

Helperby Therapeutics says it can ‘outsmart’ antimicrobial resistance by rejuvenating old and existing antibiotics to make combination therapies.

Evoke’s experience with Thermo wins Patheon nasal metoclopramide contract

13-Nov-2017 By Dan Stanton

Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.