Delivery formulations

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.

Codexis expects ‘significant revenue’ from Nestlé collaboration

13-Nov-2017 By Dan Stanton

The recently inked development partnership with Nestlé Health Science could net Codexis upwards of $350m.

Copaxone competition and generic price erosion hits Teva’s Q3

07-Nov-2017 By Dan Stanton

Teva has lowered its 2017 guidance on the back of higher-than-expected generic price erosion and lower-than-expected Copaxone sales due to competition.

DowDuPont completes FMC acquisition, bolsters excipient biz

07-Nov-2017 By Dan Stanton

The acquisition of FMC Corporation's health and nutrition business gives DowDuPont “one of the broadest pharma offerings to serve the growing excipients industry,” the firm says.

Fresenius investing in US to prep for injectables surge

06-Nov-2017 By Dan Stanton

Generic injectables are a solution to rising healthcare costs says Fresenius, which is expanding its US manufacturing network to benefit from the long-term growth prospects.

Novartis to pay $3.9 bn for radiopharma drug & biz

31-Oct-2017 By Flora Southey

Novartis has announced plans to buy radiopharmaceutical firm Advanced Accelerator Applications (AAA), which will add neuroendocrine tumour treatment Lutathera to its portfolio.

InMed’s eye-catching cannabinoid ‘lense’ for drug delivery

30-Oct-2017 By Flora Southey

InMed Pharmaceuticals is developing a gel-based cannabinoid drug for eye diseases such as glaucoma, which it says could be cheaper and more accessible than cannabinoid-based products on the market.

Lonza maintains 2017 target and says US plant and Capsugel integration on track

26-Oct-2017 By Gareth Macdonald

Lonza has reaffirmed its full-year sales and earnings forecast and updated about its US operations and the integration of Capsugel.

update

US FDA rejects Translarna and says additional trial and CMC data is needed

26-Oct-2017 By Gareth Macdonald

The US FDA has rejected the muscular dystrophy candidate Translarna (ataluren), telling PTC Therapeutics more trial data is needed to prove the drug works and asking for additional information about how it is made.

MHRA pulls Evertogen's GMP certificate after inspection

25-Oct-2017 By Gareth Macdonald

Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.

Pfizer expands Japan contracting offering touting market knowhow

22-Oct-2017 By Gareth Macdonald

Pfizer has expanded its contract manufacturing offering in Japan, adding capacity to make highly potent solid dosage forms at its facility in Nagoya.

news in brief

STA to open catalyst screening centre in Changzhou in November

19-Oct-2017 By Gareth Macdonald

STA Pharmaceutical Co is setting up a metal catalyst-screening center at its facility in Changzhou, China.

news in brief

GT Biopharma starts making carbamazepine tabets for planned trials

17-Oct-2017 By Gareth Macdonald

GT Biopharma Inc. has started making a non-opioid pain drug that uses a formulation technology licensed from Accu-Break Pharmaceuticals Inc.

Grace licenses Formac's bioavailability enhancement tech

17-Oct-2017 By Gareth Macdonald

WR Grace & Co has licensed rights to a bioavailability enhancement technology from Formac Pharmaceuticals NV.

CordenPharma ups Swiss API development services

16-Oct-2017 By Staff Reporter

CordenPharma has invested in its Swiss API development services a week after buying a manufacturing plant from Pfizer.

Depomed warns of Nucynta ER delays citing damage to Puerto Rico CMO

11-Oct-2017 By Gareth Macdonald

Depomed Inc. says supplies of the extended release version of Nucynta will be delayed as a result of damage to a Puerto Rico manufacturing plant caused by hurricane Maria.

Biotech Week Boston

Shire: Getting smart with delivery tech key in developing orphan drugs

04-Oct-2017 By Dan Stanton

Rare disease therapies need to be administered in a way that suit the patient according to Shire CEO Flemming Ørnskov, who says smart, flexible delivery devices are core to the firm's product development strategy.

Red light for blue oxy: US FDA rejects Rexista's anti-abuse traits

26-Sep-2017 By Flora Southey

The US FDA has rejected Intellipharmaceutics’ oxycodone product Rexista, raising concerns about the efficacy of its anti-abuse measures.

Anti-malaria drug casts light on cancer therapy

25-Sep-2017 By Flora Southey

A treatment combining anti-malaria drug artemisinin and light-sensitive molecules could kill cancer cells and hinder tumour growth, say researchers.

In cold (and thin) blood: snake venom to reverse anticoagulant treatments

21-Sep-2017 By Flora Southey

The use of snake venom protein-inspired candidate PseudoXa in patients taking anticoagulants, could combat severe bleeding in emergency surgery, says VarmX.

US FDA warns Korean & Chinese firms for cGMP violations

20-Sep-2017 By Flora Southey

The US Food and Drug Administration (FDA) has issued warning letters to Korean company Firson Co. and Chinese firm Wuxi Medical Instrument Factory, citing sterilisation violations.

Roche Spanish plant becomes eighth solid dose site for Recipharm

20-Sep-2017 By Dan Stanton

Recipharm has acquired a Spanish manufacturing plant and signed a supply deal with former owner Roche for a range of solid dose products worth €35m a year.

Dry powder development: Vectura’s BI alternative backed by Pulmatrix

19-Sep-2017 By Flora Southey

Vectura has advanced plans to develop a dry powder inhaler to treat patients with chronic obstructive pulmonary disease (COPD) for the US market.

Recipharm to make clinical trial cancer candidate for Kancera

18-Sep-2017 By Dan Stanton

Recipharm will make clinical trial capsules to support oncology candidate KAND567, a former AstraZeneca Fractalkine receptor inhibitor being developed by Kancera.

Update

Single shot in 'tiny coffee cups’ could deliver multiple vaccines, MIT

18-Sep-2017 By Dan Stanton

3-D microparticles which degrade at differing rates in the body could allow multiple doses of drugs or vaccines to be administered in a single injection, say MIT researchers.

BMS inks $105m deal to access Halozyme drug delivery tech

14-Sep-2017 By Dan Stanton

Bristol-Myers Squibb will also make up to $160m in milestone payments for each candidate developed using Halozyme Therapeutics’ large-volume biologics delivery platform.

German inspectors find problems at Dr Reddy's' Duvvada plant

11-Sep-2017 By Gareth Macdonald

German regulators have found problems as Dr Reddy’s’ drug formulations plant in Duvvada, Vishakapatnam.

Roche sells Italian formulations plant to CMO Delpharm

06-Sep-2017 By Dan Stanton

Delpharm has been contracted to make solid and liquid forms for Roche after buying the facility in Milan.

Oramed looking for commercialisation partner for oral insulin in US

06-Sep-2017 By Dan Stanton

Oramed is eying up commercial partnerships for its oral insulin candidate following a positive meeting with the US FDA to discuss an appropriate approval pathway.

Navesta opens LKR1.4bn sterile drug plant in Sri Lanka

04-Sep-2017 By Gareth Macdonald

Navesta Pharmaceuticals had opened a sterile drug manufacturing facility in Horana, Sri Lanka.

Gilead aims to expand CAR-T manufacturing capabilities post-Kite acquisition

01-Sep-2017 By Dan Stanton

Gilead says it is committed to driving down costs of CAR-T manufacturing after agreeing to buy late-stage cell and gene therapy firm KitePharma for $11.9bn.

US FDA says Acorda can't file Inbrija NDA and asks for production data

29-Aug-2017 By Gareth Macdonald

The US FDA has refused to let Acorda Therapeutics Inc. file an NDA for Inbrija, its inhalable version of levodopa.

Catalent looking to parenteral dosage form capability for future expansion

29-Aug-2017 By Dan Stanton

Catalent says it will focus its M&A strategy to fill the injectables capability gap in its CDMO offering.

Being for the $11.9bn benefit of investors of Kite: Gilead jumps into CAR-T

28-Aug-2017 By Dan Stanton

Gilead will add a late-stage CAR T-cell candidate and a facility in California capable of treating 5,000 patients per year through the $11.9bn deal.

Lonza expands Swiss drug product site, adds 50 jobs

25-Aug-2017 By Flora Southey

Lonza will feed demand for its drug quality testing and formulation capabilities through an expansion at its Drug Product Services site in Basel, Switzerland.

Hikma upping injectables capacity by as much as 500% by end of 2017

22-Aug-2017 By Dan Stanton

Hikma has ramped up capacity at manufacturing facilities in the US and Portugal manufacturing to meet the growing demand for its lyophilised and oncology products.

BASF outlines plans for $50m Mumbai R&D campus

16-Aug-2017 By Gareth Macdonald

BASF has confirmed the innovation campus it is setting up in India will employ 300 people and cater for multiple markets across Asia and elsewhere.

Aerie Pharma to use DSM polymers to develop eye drug delivery tech

16-Aug-2017 By Staff reporter

Aerie Pharmaceuticals Inc will use a DSM polymer technology to develop an implant to deliver AR-13154, its wet AMD drug candidate.

BASF opens pharma formulations lab in India

03-Aug-2017 By Gareth Macdonald

BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.

Fosun and KKR extend deadline for $1.2bn Gland Pharma deal

01-Aug-2017 By Gareth Macdonald

Shanghai Fosun Pharma and KKR have agreed to extended the termination date for the former's proposed $1.2bn (€1bn) takeover of Gland Pharma.

Lupin says it fixed issue flagged by US FDA during Aurangabad audit

01-Aug-2017 By Gareth Macdonald

Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July.

German lyophilisation ramp-up could be delayed into next year, Recipharm

31-Jul-2017 By Dan Stanton

A lyophilisation expansion announced in 2013 at an aseptic facility in Wasserburg, Germany has been delayed due to lengthy approval processes, says Recipharm.

Alexion ends Moderna mRNA pact

28-Jul-2017 By Flora Southey

Alexion Pharmaceuticals says it is reducing R&D operations and terminating mRNA-focused preclinical partnerships.

Unichem outlines manufacturing plan for generic Hyzaar

26-Jul-2017 By Gareth Macdonald

Unichem Laboratories Limited has confirmed it will make its generic version of Hyzaar for the US market at three plants in India.

Recipharm installs dedicated production line for prostate cancer depot

26-Jul-2017 By Dan Stanton

Recipharm has installed a dedicated production line to make prostate cancer drug Liproca Depot for Swedish pharma firm LIDDS AB.

Torbay Pharma opens plant with sterile injectables capacity in UK

25-Jul-2017 By Gareth Macdonald

Torbay Pharmaceuticals has opened a £26m injectable drug manufacturing facility in Paignton, UK.

Mitsubishi Tanabe to pay $1.1bn for Parkinson's drug formulator Neuroderm

25-Jul-2017 By Gareth Macdonald

Mitsubishi Tanabe Pharma has agreed to pay $1.1bn (€943m) to acquire Parkinson’s disease focused formulation and drug-device developer Neuroderm Ltd.

US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

19-Jul-2017 By Gareth Macdonald

The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.