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Headlines > July 2015

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Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS

30-Jul-2015 - A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the...

European pharma: CEO talent is the new measure of company calibre

30-Jul-2015 - Industry headhunters have picked their top CEOs in European pharma, saying the most successful investors keep chief execs in place even through hard times.  

Echo's cannabis API delivery formulation could aid low solubility drugs

30-Jul-2015 - A drug delivery platform which increased the bioavailability of a cannabis-based drug candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.

Sanofi Q2 Afrezza sales far from a giant leap for MannKind

30-Jul-2015 - The €3m Afrezza has contributed to Sanofi’s revenues since launch is unlikely to subdue growing concerns from commentators surrounding its partner MannKind which developed the inhalable insulin.


CRO vs HRA trial transparency case ends in a win for industry

29-Jul-2015 - A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to...

EMD Millipore and celares team to offer PEGylation to biologic makers

29-Jul-2015 - Attaching PEG-chains to biological molecules can increase bioavailability and speed up development of protein-based therapies and biosimilars, says EMD Millipore which has inked a deal with PEGylation firm celares.

'Rough notes' and backdated signatures land Indian API maker US FDA warning

29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes...

Hikma buys B-I generics subsidiary, strengthens position in US market

28-Jul-2015 - Hikma says its $2.65bn acquisition of Roxane Laboratories will make it the sixth largest firm in the US generics space.

US FDA finalises analytical procedures and methods validation guidance

28-Jul-2015 - Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.

Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan

28-Jul-2015 - The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.


Teva to buy Allergan's generics biz for $40.5bn

27-Jul-2015 - Teva has struck a deal to buy Allergan’s generics business a week after its persistent attempts to acquire Mylan fell through.

EU and Swiss regulators strengthen ties with confidentiality agreement

27-Jul-2015 - A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.

Less than a year to risk assess excipients: IPEC Europe develops 'how to' guide

27-Jul-2015 - IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.

Sandoz shutters German and Indian production sites

23-Jul-2015 - Sandoz has revealed it will close three manufacturing sites in Germany and India.

Capsugel expanding Encap plant on rising HPAPI demand

23-Jul-2015 - Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).

First part of European fake fighting database linked to securPharm

23-Jul-2015 - The first part of a Europe-wide database intended to help identify fake drugs is operational after being linked to Germany’s securPharm system.

Funds worth €3.5tr back Alltrials, but none promise to pull cash from drug firms that don't

23-Jul-2015 - Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.

Ethiopia: GMP compliant local drug and API sector would yield health and economic benefits

22-Jul-2015 - Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.

Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters

22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.

Novartis defends Afinitor after thrashing from BMS and Exelixis trials

22-Jul-2015 - Novartis expects sales of Afinitor to slow after BMS and Exelixis announced this week their pipeline drugs beat it on renal cell carcinoma.

Lonza: global hedge helped offset currency exposure but Visp still a risk

22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.

Johnson Matthey’s API business flat in Q1 on timing of opiate API orders

22-Jul-2015 - Johnson Matthey saw lower demand for opiate APIs in the three months to the end of June, which offsett more solid performance by its attention deficit hyperactivity disorder (ADHD) drug...

IPEC calls on FDA to establish new review process for novel excipients

22-Jul-2015 - As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of...

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