Delivery formulations

Med Prep execs accused of lying about sterility practices at compounding facility

02-Mar-2015 By Gareth Macdonald

Med Prep Consulting execs committed fraud and violated the Federal Food, Drug and Cosmetic Act (FDCA) according to the US DoJ, which has accused the New Jersey compounder of knowingly selling drugs produced in unsanitary conditions.

Salix latest purchase by Valeant after Dendreon deal

26-Feb-2015 By Fiona BARRY

Valeant has signed a $14.5bn deal to acquire GI drugmaker Salix days after agreeing to purchase Provenge-maker Dendreon.

Shire steps further into rare diseases with $70m acquisition

25-Feb-2015 By Zachary Brennan

Shire has acquired privately-held Meritage for an upfront fee of $70m and additional contingent payments based on the achievement of development and regulatory milestones.

Drug delivery tech’s shares skyrocket as it helps Novo Nordisk clear Phase II hurdle

23-Feb-2015 By Zachary Brennan

A potential Type 2 diabetes drug from Novo Nordisk has met the primary endpoint of a Phase II trial and shares of Emisphere Technology, which helped to formulate the oral version of semaglutide, jumped by as much as 70% on Friday.

Fresenius Kabi sells cancer compounding biz to NewCo Pharma

17-Feb-2015 By Gareth Macdonald

Fresenius Kabi has sold its cancer drug pharmacy network CFL GmbH to NewCo Pharma GmbH five years after spending €42m to buy compounding capacity in Germany.

Suboxone sales down as opioid addiction drug market intensifies

12-Feb-2015 By Dan Stanton

Opioid addiction drug Suboxone lost market share in 2014 according to newly independent Indivior, whose management says it is not intimidated by increased competition.

Ex-Unigene execs who run Enteris add API contracting service to delivery tech licensing business

12-Feb-2015 By Gareth Macdonald

Enteris BioPharma has broadened its business beyond drug delivery tech licensing and launched a contract API manufacturing service.

One in the eye for Lucentis? Pfenex says Pfizer takeover will benefit Hospira pact

11-Feb-2015 By Gareth Macdonald

Pfenex expects its new Lucentis biosimilar partnership to benefit from Pfizer’s economic clout after the Hospira takeover completes.

Chinese researchers develop nanocarrier for pancreatic cancer drug

09-Feb-2015 By Zachary Brennan

Researchers from the Oncology Department of Tianjin Medical University Cancer Hospital in China recently published a study in Advanced Functional Materials announcing the creation of a new nano-carrier for pancreatic cancer treatments.

Inhaled insulin: Sanofi alone as Big Pharma declines to revisit past

04-Feb-2015 By Dan Stanton

Pfizer, Lilly and Novo Nordisk will not be revisiting inhaled insulin opportunities despite the US launch and expected success of Sanofi and MannKind’s Afrezza.

Halal and Kosher stamps of approval for pregnancy drug

26-Jan-2015 By Fiona BARRY

A morning sickness drug made by Duchesnay USA will now display Halal and Kosher symbols – a move the company said is the first case of Kosher certification for an oral prescription drug in the US.

EMA expands generic assessment pilot globally in response to industry

21-Jan-2015 By Dan Stanton

The EMA has responded to feedback from generic drugmakers by broadening an assessment sharing pilot to regulators outside the EU.

Novozymes predicts half-life boost for pharma business, but lets long term rev forecast slide on oil prices

20-Jan-2015 By Gareth Macdonald

Novozymes finished 2014 with higher pharma revenues thanks in part to GSK's adoption of its albumin half-life extension technology, Veltis.

MannKind: Small step for delivery tech R&D after Afrezza's giant leap

19-Jan-2015 By Dan Stanton

MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.

Capsugel buys ionic liquid tech IP to enhance lipid-based drug solubility

12-Jan-2015 By Dan Stanton

Capsugel has acquired a technology platform which uses ionic liquids to enhance the solubility of lipid-based drug delivery systems.

US pharmacy deals could cut costs of AbbVie and Gilead's HCV treatments

06-Jan-2015 By Dan Stanton

Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of the new class of treatments for America’s three million Hepatitis C sufferers.

AbbVie strikes payer deal for HCV drug to help take on Gilead

05-Jan-2015 By Dan Stanton

Abbvie’s multi-ingredient HCV treatment has been approved in the US, and following an exclusive deal with Express Scripts, could lead to a pricing war with Gilead.

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 By Gareth Macdonald

Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

In nano-rod we trust: magnetic pulse tech breakthrough for cancer drug delivery

17-Dec-2014 By Gareth Macdonald

A magnetic pulse technology that can align and push nanoparticles to points distant to magnet surfaces could finally make magnets attractive for deep tissue drug delivery according to researchers.

Sosei looks to $23bn peptide market with acquisition of tech firm Jitsubo

15-Dec-2014 By Dan Stanton

Sosei Group Corporation is looking to peptides to replenish its pipeline through the $70m acquisition of technology firm Jitsubo.

Merck & Co set to be superbug-busting superstar despite US Cubicin ruling, analyst

10-Dec-2014 By Gareth Macdonald

Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.

Axim to build Dutch facility for cannabinoid-based chewing gum drug

04-Dec-2014 By Dan Stanton

A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.

Investment in oral insulin firm could aid entry to lucrative China market

04-Dec-2014 By Dan Stanton

Oral insulin developer Oramed Pharmaceuticals is looking at China’s growing diabetes problem following a $5m investment from Guangxi Wuzhou Zhongheng.

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 By Gareth Macdonald

The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Novartis' flu vaccine in the clear over 19 deaths, says Italian regulators

02-Dec-2014 By Dan Stanton

Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 By Zachary Brennan

The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.

Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference

Pipelines not tax cutting should prompt smaller pharma mergers says AstraZeneca exec

18-Nov-2014 By Dan Stanton

2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.

Big Pharma has improved access to meds since 2012 but marketing practices still a concern says AMF

17-Nov-2014 By Gareth Macdonald

Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.

'Killer experiments' and reimbursement are the keys to VC backing says Index

17-Nov-2014 By Gareth Macdonald

Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are actually much more attractive.

DISPATCHES FROM AAPS 2014

Ebola nasal vaccine under threat as funding runs dry

12-Nov-2014 By Dan Stanton

Lack of funding is threatening development of a nasal spray vaccine shown to provide long-term protection for non-human primates against the Ebola virus, the lead researcher told this publication in an exclusive interview.

Dispatches from AAPS 2014

BARDA: Ebola is “a bioterrorism threat”

06-Nov-2014 By Fiona Barry

BARDA, the US government’s Biomedical Advanced Research and Development Authority, has revealed it sees Ebola “as a bioterrorism threat.”

Dispatches from AAPS

Encapsulating the problem? Machinery could save drugmakers up to $1m, says Capsugel

06-Nov-2014 By Dan Stanton

Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel

Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

04-Nov-2014 By Dan Stanton

Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.

dispatches from AAPS

Breaking Ad: Can virus-delivered gene therapy help meth addicts quit?

04-Nov-2014 By Gareth Macdonald

Addicts struggling to kick a meth habit could be helped by gene therapy according to the team behind a US National Institutes of Health funded project.

Life on Mars? Ground control to remotely deliver drugs in space

30-Oct-2014 By Fiona BARRY

Animal astronauts on the International Space Station will test an implant which allows doctors back on earth to deliver drugs by remote control.

Oral influenza vaccine one step closer, says Vaxart

22-Oct-2014 By Dan Stanton

A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 By Fiona BARRY

Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

News from CPHI Paris

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 By Fiona BARRY

Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.

Deadly spider found in UK shopping could provide alternative to Viagra

21-Oct-2014 By Dan Stanton

Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.

Eli Lilly to sell PR plant due to patent expirations and shifting portfolio

20-Oct-2014 By Dan Stanton

Eli Lilly is set to close one of its Puerto Rican facilities as patent expirations and a shifting portfolio reduce its need for capacity.

US FDA approves Gilead's $1,125 a pill combination Hep C drug

14-Oct-2014 By Dan Stanton

Gilead says its hepatitis C combination drug Harvoni will deliver significant healthcare savings in the long-term despite its $1,150 (€885) a pill price tag.

News from CPhI

Halal: accessing the untapped $30bn pharma market

13-Oct-2014 By Fiona BARRY

The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.

Used processing equipment industry booming due to pharma M&A, say vendors

08-Oct-2014 By Dan Stanton

Consolidation in the pharma industry is driving the second-hand processing equipment market but despite attempts to regulate the industry, a glut of online vendors means illegal drugmakers can buy such systems.

Boehringer Ingelheim invests more than €100m to expand manufacturing capacity in Germany

02-Oct-2014 By Zachary Brennan

Boehringer Ingelheim is investing more than €100m ($126m) at its Dortmund, Germany site to expand production capacity for its Respimat inhaler, which is the third time in the past four years that the company has made a capacity-expanding investment at...

Catalent calls for greater academic and industry collaboration on delivery tech

02-Oct-2014 By Dan Stanton

Catalent has urged industry and academia to share knowledge about delivery technologies to help improve drug efficacy as it signs a deal to develop ADHD treatments for Cingulate.

FDA says no to anti-addiction rule on Ritalin, painkillers

29-Sep-2014 By Fiona Barry

The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.

'Worst addiction epidemic in US history' sparks call for Hamburg's resignation

25-Sep-2014 By Dan Stanton

An anti-addiction group has called for a change in leadership at the US FDA following the approval of Zohydro and other high-dose opioid analgesics.

Acorda gains pulmonary drug delivery tech in $525 Civitas deal

25-Sep-2014 By Dan Stanton

Acorda has gained a pulmonary delivery technology and a GMP manufacturing site in Massachusetts along with a Parkinson’s disease candidate in its $525m (€410m) acquisition of Civitas.

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 By Fiona Barry

The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.