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Breaking News on Contract Research, Manufacturing & Clinical Trials

API firm Unimark Remedies warned by US FDA about Indian plants

25-Aug-2016 - The US FDA has warned API manufacturer Unimark Remedies about unsanitary conditions at its facility in Vapi and Bavla in India.

CMO contracts will transfer to Pfizer

Pfizer to buy AstraZeneca's antibiotic business in deal worth up to $1.5bn

24-Aug-2016 - Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next...

Engineering Pharma

'Americanizing' a Japanese blister machine

23-Aug-2016 - The Eagle is MHI’s Americanized version of its PF-D1S – a compact, servo-driven blister machine, and the company’s first entrance into the North American marketplace.

BASF API biz boosts Siegfried in H1, but IT integration costs hit profits

22-Aug-2016 - Siegfried Holding AG has attributed a surge in API sales to the drug ingredients business it bought from BASF last year, but says that integration costs hurt profits.

Evolva to apply yeast-based production tech to APIs for US biotech partner

18-Aug-2016 - Evolva has agreed to develop new ways of making APIs for an unnamed US biotech using its fermentation system. 

Public Patheon's $2bn warchest may bolster biologics offering, analyst

17-Aug-2016 - Biomanufacturing demand will drive revenues for Patheon according to an Evercore ISI analyst, who has predicted the newly-listed CDMO will strengthen its capabilities through M&A.

Ash Stevens acquired by India-based CDMO

16-Aug-2016 - Ash Stevens has been acquired by Piramal Pharma Solutions, an India-based CDMO, in what the CEO said is an "incredibly powerful combination."

update

US FDA changes policy on switching hard gel capsule suppliers

16-Aug-2016 - Drug manufacturers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the US FDA this week.

Alcami plans to increase API production capacity

16-Aug-2016 - Alcami has announced plans to expand its facilities in Germantown, Wisconsin, in order to increase its Active Pharmaceutical Ingredient (API) production.

Serialization initiative makes progress towards uniform track and trace model

16-Aug-2016 - The initiative brought together competing vendors working “side by side,” focusing on a common goal of creating industry-wide standards.

WuXi AppTec subsidiary passes third US FDA inspection

15-Aug-2016 - WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.

SRF board approves new chloromethane plant to meet Indian pharma demand

11-Aug-2016 - SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports. 

Catalent wins early-phase contract for Arch's inhaled orphan drug

11-Aug-2016 - Arch Biopartners has selected Catalent to carry out studies and make batches of its orphan drug candidate AB569 for upcoming clinical trials.

Catalent and Zumutor combine cell line tech to increase antibody ADCC

10-Aug-2016 - Catalent and Zumutor Biologics have combined their technologies to create antibodies with enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without compromising production levels.

Engineering Pharma

Antares Vision launches serialization unit with PCI Pharma Services

04-Aug-2016 - Antares Vision has developed a new serialization unit in conjunction with the contract manufacturing organization (CMO), PCI Pharma Services.

AMRI's API revs up in Q2 after Gadea offsets plant closure and lower royalties

04-Aug-2016 - Steroid API firm Gadea Pharmaceuticals helped AMRI grow revenue in the second quarter offsetting flat royalties and the impact of the closure of its site in Holywell, Wales.

CRO Velesco Pharma adds compound management services

03-Aug-2016 - The contract research organization (CRO) Velesco Pharma has opened a new laboratory in its Plymouth, MI-based facility to support an increased demand for materials management.

update

Keryx halts Auryxia production citing API related manufacturing problems

02-Aug-2016 - Keryx Biopharmaceutical's CMO has halted production of Auryxia (ferric citrate) as a results of manufacturing problems.

Hemispherx hires Avrio as Ampligen CMO while it tries to win US approval

01-Aug-2016 - Hemispherx Biopharma has hired Avrio Biopharmaceuticals to make Ampligen while it continues to try and win US approval for rejected candidate chronic fatigue syndrome (CFS) drug candidate.

West: Amgen mAb approval helps validate drug delivery tech

01-Aug-2016 - Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.

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.

Q&A

Biotech growth driving 'surge in demand'

27-Jul-2016 - Symbiosis Pharmaceutical Services is preparing for increasing growth in the outsourcing sector with “a major investment” at its sterile filling facility underway and a recent hire in the US.

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.

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.

The patent lives in Hospira v MedCo: good news for CMOs

21-Jul-2016 - The Medicines Company announced last week  that its Angiomax patent has been upheld – an 'important court decision' which affirms that working with CMOs won’t invalidate a company's patent....

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