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US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

19-Jul-2017 - 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.

Pfizer hires Catalent to make smaller format Advil using Optigel tech

18-Jul-2017 - Pfizer Inc. has awarded Catalent Pharma Solutions the long-term manufacturing contract for a smaller version of its over-the-counter (OTC) painkiller Advil (ibuprofen). 

Idifarma adds contract capsule filling to offering

18-Jul-2017 - Idifarma has bolstered its capsule filling capabilities at its manufacturing plant in Pamplona, Spain.

Elite halts trials of reformulated SequestOx after BE data falls short

10-Jul-2017 - Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.

Bayer ends methamphetamine abuse deterrent partnership with Acura

06-Jul-2017 - Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.

Immediate-release formulation means fewer pills and more flexibility, says Roche

03-Jul-2017 - The European Medicines Agency has approved a new tablet formulation of Esbriet (pirfenidone), which Roche says reduces pill-load and increases dosing flexibility for patients with a rare lung disease.

Patheon to spend $45m on manufacturing plants ahead of Thermo takeover

30-Jun-2017 - Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.

News in brief

Zynerba starts Ph I study of cannabinoid pain patch

26-Jun-2017 - Zynerba Pharmaceuticals Inc has begun a Phase I trial of cannabinoid patch it is developing for fibromyalgia and peripheral neuropathic pain.

Tetraphase hires Patheon to make its synthetic antibiotic eravacycline

22-Jun-2017 - Tetraphase Pharmaceutical has hired Patheon UK Limited to make and test the synthetic antibiotic eravacycline.

Takeda inaugurates €100m German oral solid dose plant

20-Jun-2017 - Takeda has completed a €100m ($112m) oral solid dosage production facility in Germany.

News in brief

Lubrizol invests $60m in drug production at Particle Science plant

12-Jun-2017 - The Lubrizol Corporation has invested $60m (€53m) in its Particle Science drug manufacturing business.

'Talking' smart pill looks to overhaul prescription opioid space and stop abuse

08-Jun-2017 - Pop Test Abuse Deterrent Technologies has received a patent for an opioid drug delivery and abuse deterrent ‘smart pill’ it says can prevent death, theft, diversion and counterfeiting.

Takeda breaks ground on $45m Ninlaro plant in Ireland

06-Jun-2017 - Takeda has begun construction of an Irish facility to support production of its orally delivered blood cancer peptide Ninlaro (ixazomib).

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

01-Jun-2017 - Rho has been contracted to support Evoke Pharma’s planned NDA submission for its nasal delivery formulation of metoclopramide, Gimoti.

Spider silk challenges cost of biological lung surfactant

31-May-2017 - Researchers at Sweden-based Karolinska Institutet have developed a synthetic lung surfactant using DNA sequences derived from spider silk proteins.

Long-acting insulin price concerns challenge WHO proposal

30-May-2017 - Non-profit organisations have challenged the proposed addition of long-acting insulin analogues to the World Health Organisation’s Model List of Essential Medicines, citing price as a key factor.

Granules India confirms $35m US plant expansion will create jobs

24-May-2017 - Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.

Eye drops to replace painful injections in AMD patients

24-May-2017 - The University of Birmingham has developed a cell-penetrating peptide it claims could be used to make eye drop versions of age-related macular degeneration drugs currently delivered by injection.

Aduro and Merck & Co to test Keytruda and CRS-207 in second cancer study

22-May-2017 - Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.

Russia clears Saneca Pharma to supply dosage forms made at Slovakian site

16-May-2017 - Russian Regulators have issued Saneca Pharma with a cGMP certificate after inspecting its facility in Hlohovec, Slovakia.

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