Breaking News on Global Pharmaceutical Technology & Manufacturing

Hovione gets US patent for simple, patient-inspired inhaler

15-Apr-2014 - Hovione has obtained a US patent for a cheap capsule-based dry powder inhaler that it claims is cheaper for manufacturers to produce and easier for patients to use.

Pfizer, Novartis developing MenB vaccines to combat new strain

09-Apr-2014 - Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines. 

Molecular Profiles' investment makes HME (bio)available for clients

08-Apr-2014 - Molecular Profiles has invested in hot melt extrusion (HME) and nano milling capabilities citing client demand for improving the bioavailablity of drugs.

Fiocruz to help make pediatric formulation of bitter schistosomiasis drug

08-Apr-2014 - A consortium developing treatments for children infected by parasitic worms has signed up Brazilian drugmaker Fiocruz as a formulation and manufacturing partner to support upcoming clinical trials.

Two giant leaps for MannKind? US approval nod good for delivery tech too

02-Apr-2014 - A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.

'Biodegradable battery' could be used to deliver drugs, researcher says

01-Apr-2014 - An intracochlear drug delivery implant could be powered over several months by a biodegradable battery according to an expert.

UPDATE

Goodwin and Aspyrian team to deliver cancer-killing drugs by infrared light

27-Mar-2014 - ADC-makers could avoid using costly cytotoxics in antibody-drug conjugates (ADCs) by using near‐infrared (NIR) light to activate targeted cell-killing payloads, says Goodwin who has team up with Aspyrian Therapeutics.

Janssen Button? Will GSK's F1 team up prompt other collaborations?

26-Mar-2014 - GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow developed in Formula One pit lanes by partner, McLaren.

US FDA issues new bioavailability guidelines

25-Mar-2014 - The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).

Bioavailability breakthrough key to new cancer drug OKed in Japan

24-Mar-2014 - Japan has become the first country to approve a new cancer pill that treats disease by interfering with DNA replication in tumour cells.

Bioavailability Breakthrough: Aegis’ enhancement tech works in pill form

19-Mar-2014 - Aegis Therapeutics claims a technology developed to improve the bioavailability of drugs delivered through the nose has a similar solubility enhancement effect in a solid dosage form.

Novo Nordisk buys rights to Caisson’s drug-extending biotech

18-Mar-2014 - Caisson Biotech has licensed its drug-extending technology for injectables to Novo Nordisk.

US FDA's "safety by design" push driving pill coating trends says Colorcon

11-Mar-2014 - The US Food and Drug Administration (FDA) push for safety by design is driving development in pill coating according to Colorcon MD Steve Facer who took in-Pharmatechnologist.com on a tour of the firm's facility in Dartford, UK.

US FDA approves AZ's Bydureon Pen as Lilly eyes GLP-1 market

05-Mar-2014 - The US FDA has approved a weekly single-use syringe for AstraZeneca’ Bydureon as Lilly reveals its ambition in the GLP-1 drug market.

Anti-addiction formulation of super-strong opioid unclear

05-Mar-2014 - Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation uses anti-abuse technology.

Europe slow to adopt anti-abuse formulations and tech, says expert

27-Feb-2014 - European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.

FDA re-evaluates 5-year NCE exclusivity to incentivize development of fixed-combo products

25-Feb-2014 - The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products. 

Insulin pill tech can be used more widely says Oramed

18-Feb-2014 - Debate rages over the significance of safety data from a trial of Oramed’s oral insulin pill, but the firm is still confident in its delivery technology.

UPDATE 1

Actavis to acquire Forest labs in $25bn takeover

18-Feb-2014 - Actavis has confirmed it will acquire Forest Laboratories in a deal worth up to $25bn (€18bn) following rumours last night.

Gold ‘nanoshells’ may offer new delivery option for cancer, hypothermia drugs

17-Feb-2014 - A new study published in the Institute of Physics Science reveals that Chinese researchers have developed gold nanoparticles that may help deliver cancer treatments to specifically targeted cells.

NIH partners with 10 pharma companies to tackle major disease targets

11-Feb-2014 - The National Institutes of Health and 10 pharmaceutical companies have launched a partnership to transform the current model for identifying and validating promising biological targets for Type 2 diabetes, Alzheimer’s disease, lupus and rheumatoid arthritis.

Targeted drug delivery driving partnerships, says expert

06-Feb-2014 - An increased trend in dealmaking for targeted drug delivery last year will continue to drive partnerships in 2014, according to a pharmaceutical partnering expert.

Unilife: More contracts to come for Ocu-ject delivery platform

05-Feb-2014 - Unilife says it expects more contracts for its intravitreal injection technology Ocu-ject following the signing of a major deal last quarter.

Lupin buys Dutch delivery tech firm for injectables entry

03-Feb-2014 - Lupin Ltd has bought Dutch delivery technology company Nanomi BV in a deal that moves the Indian generics firm into the complex injectables space.

Clarus says oral testosterone bulks muscles, not liver

30-Jan-2014 - Clarus Therapeutics has submitted to the FDA a testosterone replacement it claims overcomes the toxicity problems that have plagued other oral drugs like methyltestosterone.

Spotlight

EMA to rejig variations procedures and industry contact staff in April

EMA to rejig variations procedures and industry contact staff in April

Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation...

Janssen Button? Will GSK's F1 team up prompt other collaborations?

Janssen Button? Will GSK's F1 team up prompt other collaborations?

GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow...

Indian API maker slammed with US FDA Warning over data issues

Indian API maker slammed with US FDA Warning over data issues

Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter...

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

The US FDA has published guidance of how sponsors should best document the bioavailability of products for...

Bioavailability breakthrough key to new cancer drug OKed in Japan

Bioavailability breakthrough key to new cancer drug OKed in Japan

Japan has become the first country to approve a new cancer pill that treats disease by interfering...

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