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Headlines > May 2017

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Cambrex continues to up capacity with more than $200m invested in 5 years

31-May-2017 - Cambrex Corporation has increased new capacity at its Sweden-based cGMP as the manufacturer focuses on market demand and customer need, says VP.

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.

Visible particulates and leaking bags land B Braun Cali plant with FDA warning

31-May-2017 - The US FDA has slammed B. Braun Medical for repeatedly failing to thoroughly investigate quality concerns at a drugmaking facility in California.

Cure Pharma’s API delivery tech on the tip of the tongue

30-May-2017 - Cure Pharmaceutical has submitted a patent application for an oral film delivery technology it says can combine several active pharmaceutical ingredients without negative interaction. 

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.

Drug industry disaster concerns prompted lab expansion says Intertek

30-May-2017 - Drug industry concerns about natural disasters are driving demand for ‘storage-only’ stability testing according to Intertek, which has announced plans to expand its UK lab.

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 - The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

CDMO Recro expands manufacturing capabilities at former Alkermes site

24-May-2017 - Recro has added a new tablet manufacturing suite that enables it to compress single- and bi-layer tablets at commercial speeds.

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.

US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

24-May-2017 - The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

Looking to the long-term: Serialisation regulations here to stay, Tracelink

23-May-2017 - Pharma and CMOs must start addressing their serialization needs ahead of 2019’s EU Falsified Medicines Directive, says Tracelink which is bringing its supply chain event NEXUS to Barcelona next month.

EMA proposal concerns: “Public health trumps commercial confidentiality”

23-May-2017 - Proposed amendments to the European Medicines Agency’s (EMA) access to documents policy have been criticised by medicines watchdogs, including not-for-profit Health Action International and Prescrire.

DSM Sinochem wins patent infringement ruling against Sinopharm Weiqida

23-May-2017 - The High Court of Delhi, India, has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement of DSM Sinochem Pharmaceuticals’ enzyme-based antibiotic production IP.

US FDA warns liquid drug firms to test for Burkholderia cepacia

23-May-2017 - Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

EMA committee says AB Science’s Masitinib should not be approved in light of GCP failings

22-May-2017 - AB Science’s candidate cancer drug Masitinib (masitinib) should not be approved according to an EMA committee, which cited concerns about data and failings identified in a 2015 trial.

Synlogic takeover secures Mirna’s NASDAQ listing + $40m cash

22-May-2017 - Synlogic has announced it will conduct a reverse merger with failed Mirna Therapeutics, to focus on metabolic and inflammatory diseases and cancer.

US triples indications for Kalydeco without needing new clinical data

22-May-2017 - The US FDA has approved Vertex’s cystic fibrosis drug Kalydeco (ivacaftor) to treat a further 23 genetic mutations based solely on in vitro data.

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.

IFPMA launches Alliance to track drug firms' progress in the fight against ‘superbugs'.

Charity urges drug industry to consider supplier role in “superbug” spread

18-May-2017 - Drug manufacturers, retail pharmacies and regulators have a role to play in curbing antimicrobial resistance say campaigners urging industry to ensure their API suppliers are not part of the problem.

CEFIC: members will only sell GHB intermediate to legitimate industry users

18-May-2017 - Cefic has agreed to make sure its members only sell the intermediate gamma butyrolactone (GBL) to legitimate users to stop it being abused or used in “date rape” drug GHB.

500 jobs to go as Teva exits troubled Hungary plant

17-May-2017 - Teva Pharmaceuticals has confirmed it intends to sell or close its Gödöllő manufacturing plant by the end of 2018. 

CPhI North America

Cambrex invests $2.4m at former PharmaCore site

17-May-2017 - Cambrex Corporation is installing a fourth reactor suite at its High Point, NC-based facility as it continues to grow with its customers in the market, says company VP at CPhI North America....

France's ANSM raises GMP concerns at Brazilian aseptic plant

17-May-2017 - Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.

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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