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Headlines > July 2016

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Cambrex predicts flat generic API sales for 2016

Cambrex to start work on Pharma 4 API site in 2016

28-Jul-2016 - Cambrex has said it will invest around $20m in its Pharma 4 API facility before the end of the year in an effort to get ahead of the capacity utilisation curve.

Scientists at ex AstraZeneca site join Obama’s $350m antibiotic effort

28-Jul-2016 - Scientists at AstraZeneca’s former R&D site in Alderley Park will play a key role in researching antibiotics and the spread of resistance under an initiative launched by US President Barack...

Dr Reddy’s Q1: warning letter ‘significantly impacted our earnings’

28-Jul-2016 - US FDA warnings and Venezuela's economic crisis have contributed to “a challenging quarter” for Dr Reddy’s, with its API business being particularly affected.

Amgen begins to see results from manufacturing efficiency drive

28-Jul-2016 - A restructuring programme which closed two US facilities and slashed hundreds of jobs has paid off says Amgen, attributing increased margins to better manufacturing efficiencies.

Saneca inks Eastern Europe manufacturing and registration deal with Xantis

27-Jul-2016 - Slovakian CDMO Saneca Pharma will make more than 20 generic products for Xantis after selling the registration dossiers to the Swiss firm.

BASF reports lower demand for remaining APIs in Q2

27-Jul-2016 - BASF has said it saw lower demand for its remaining active pharmaceutical ingredients (APIs) in the second quarter.

GSK commits to UK manufacturing with £275m investments across three sites

27-Jul-2016 - GSK will pump £275m ($360m) into its UK manufacturing network and says the country has a “leading position in life sciences” despite the recent Brexit vote.

QuVa buys New Jersey manufacturing plant citing access to regional markets

26-Jul-2016 - QuVa Pharma has agreed to buy a manufacturing facility in New Jersey, US at which it plans to compound sterile pharmaceutical products for hospitals.

EMA proposing changes to FIH clinical trials, accepting comments

26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.

US FDA finds cGMP deviations at ALK-Abello facility in Denmark

26-Jul-2016 - The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).

Single-use driving double digit growth for Pall and Sartorius

26-Jul-2016 - Bioprocess equipment vendors Pall and Sartorius have each cited demand for single-use technologies as a growth driver in the first half 2016.

US FDA won't OK eye pain candidate until Ocular Therapeutix addresses production concerns

26-Jul-2016 - The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made. 

Roche getting under the skin of biosimilar competition

25-Jul-2016 - Subcutaneous versions of its biologic blockbusters - including Mabthera and Herceptin - will help protect against biosimilar competition, says Roche.

Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn

Sandoz repeats tests and Teva pulls malaria pill as EMA calls for suspension of Semler trialled drugs

25-Jul-2016 - Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.

Recipharm: Q2 rev up on M&As, higher demand and anti-radiation med

25-Jul-2016 - Acquisitions, higher demand for sterile liquid processing and a surge in Thyrosafe orders helped Recipharm offset pricing pressure in Portugal and lower UK sales in Q2.

Teewinot gets US patent for bioreactor used to make synthetic cannabinoid APIs

22-Jul-2016 - Teewinot Life Sciences has been granted a US patent for a bioreactor it uses to produce synthetic cannabinoids.

update

US investor buys J&J's opiate API business and announces restructuring

21-Jul-2016 - SK Capital has rejigged the senior teams at opiate API maker Noramco and raw material supplier Tasmanian Alkaloids just weeks after buying the firms from Johnson & Johnson (J&J)....

EMA proposes changes to Ph I guidelines after fatal BIA 10-2474 trial

21-Jul-2016 - European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.

GSK to expand recall of antibiotics made at Worthing API unit

21-Jul-2016 - GSK will recall more antibiotics made at a UK API unit that has been offline since the US FDA raised contamination concerns last year.

Patheon will list on NYSE today

21-Jul-2016 - API and drug maker Patheon will begin trading on the New York Stock Exchange under the symbol PTHN later today.

Lonza: Biologic APIs boosted H1 revs and CAR-T deal will help sustain growth in H2

20-Jul-2016 - Lonza has increased its 2016 earnings guidance after strong H1 growth of its biologic APIs business.

Johnson Matthey: Q1 API revenues down on order timings

20-Jul-2016 - Johnson Matthey said a slight decrease in API sales during the first quarter of its fiscal year was due to the timing of customer orders.

Pharma AMAC supplies look more secure: New firm MCM to buy Ineos' Barex resin IP

20-Jul-2016 - MSM Poly LLC has signed a non-binding agreement to buy IP that underpins Ineos’ Barex resins, which are used to make pharmaceutical and food packaging.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

China's complex API regs fuelling US meth problem says congressional committee

19-Jul-2016 - Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major...

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