Latest Biotechnology, Pharmaceutical and Healthcare News from Elsevier Business Intelligence

Repros Needs Another Mid-Stage Trial For Proellex In Uterine Fibroids

FDA also recommends longer-duration Phase III trials of the vaginally-administered selective progesterone receptor modulator than the sponsor envisioned. Primary endpoint will measure blood loss; agency stresses that bulk symptoms and other patient-r...

St. Jude, Boston Scientific Release Encouraging Renal Denervation Data At EuroPCR

New clinical data from St. Jude Medical’s and Boston Scientific’s trials of renal denervation devices to treat hypertension show both companies are making progress in their development of these novel blood pressure therapies, but they both remain...

India Adopts Guidelines To Comply With EU Drug-Quality Import Rules

India drug regulators issued new GMP guidelines, effective July 2, for complying with demands by the European Union covering exports of APIs to its 27 member nations.

J&J Pakistan Seeks Buyer As MNCs Reconsider Local Market

Johnson & Johnson Pakistan is looking for a buyer for the subsidiary, which produces Janssen brands locally for the Pakistan market, according to sources.

Saudi Arabia Cites Foreign Patents Of Coronavirus For Slowing Diagnosis

Saudi Arabia health authorities accused foreign researchers of slowing its ability to diagnose a SARS-like virus that has affected the country and has killed 22 people globally within the past year.

Emerging Company In An Emerging Market: Generon Sees Quality And Price As Litmus Test

Generon in Shanghai was founded by former Hutchison Medipharma employees to target a niche market between expensive import drugs and lower quality domestic products.

Guangdong May Group Drugs Into Five Types For Separate Price Review

Guangdong has released its pharma procurement draft rules for consultation, stating it would use a third-party online platform to request EDL drug tenders for all public hospitals.

EWG Supports Nano-Engineered Mineral Sunscreens In 2013 Report

Sunscreens containing zinc oxide and titanium dioxide nanoparticles rate relatively highly in the Environmental Working Group’s annual Sunscreen Guide, though the advocacy group says greater transparency is needed regarding products with nano-engin...

J&J Sees New MOAs For Refractory Populations As Anti-Depressant For Neuro Sales

J&J’s five key therapeutic areas appear to be operating on all cylinders, based on presentations at the company’s annual analyst meeting. In neuroscience, already one of its core fields, it is expanding its anti-psychotic and mood disorders f...

J&J Sees New MOAs For Refractory Populations As The Anti-Depressant For Neuro Sales

J&J’s five key therapeutic areas appear to be operating on all cylinders, based on presentations at the company’s annual analyst meeting. In neuroscience, already one of its core fields, it is expanding its anti-psychotic and mood disorders f...

Compounding Legislation Remains Stuck On Definitions Even As House Budges

Rep. Griffith is drafting legislation based on the guidance FDA had in development before the NECC crisis struck, but the agency says it was not intended to fix its oversight problems, and FDA is also expressing dissatisfaction with the Senate’s bi...

Nearly All Drugs Pass China’s Second National Drug Quality Report For 2013

The Second Drug Quality Announcement of 2013 was released by China FDA, reporting that 99.3% of the 2,885 batches of 18 drugs passed evaluations.

China FDA Green Channel For Innovative Devices Draws Comment

China FDA’s efforts to speed approval of innovative medical devices and re-registration need clearer definitions of innovative devices, according to industry comments.

China’s Monthly Device Export Prices Slightly Lower In March 2013 vs. 2010 Levels

China’s monthly medical device export prices in March 2013 were in general slightly lower than in 2010.

Direct Contact With Producer Cuts Distribution Costs In China

A medical research institute owner shared his experience of selling generic drugs at low prices by cutting middleman costs and directly obtaining drugs from manufacturers.

[Ironwood] publicly sells Class A common shares to net $129.3mm

In a follow-on public offering, [Ironwood Pharmaceuticals Inc.] (guanylate cyclase type C (GC-C) agonists for GI disorders, plus early-stage neurological, cardiovascular, and allergy candidates) has netted $129.3mm by selling 10.5mm Class A common sh...

Series B round brings $48.2mm to [Karyopharm]

[Karyopharm Therapeutics Inc.] (nuclear transport modulators for cancer) plans to use the $48.2mm raised through a Series B round to fund clinical trials of its KPT330, a Phase I compound for advanced, relapsed, or refractory blood and solid tumors....

[NanoString Technologies] plans IPO

Life sciences company [NanoString Technologies Inc.] (translational research and molecular diagnostics) has filed for an IPO on Nasdaq.

[Elan] spins off [Speranza Therapeutics] to develop CNS candidate ELND005

[Elan Corp. PLC] is spinning off ELND005 (formerly AZD103; scyllo-inositol), its Phase II small-molecule beta-amyloid aggregation inhibitor/myo-inositol level regulator for neurodegenerative conditions, to [Speranza Therapeutics] (also known as Spera...

[ElsaLys Biotech] spins out of [Transgene], raises €2.1mm in Series A round

Immunotherapeutics company [Transgene SA] has spun out [ElsaLys Biotech], and participated in the monoclonal antibody firm’s €2.1mm ($2.7mm) Series A round, which also included Sofimac Partners.

[EDAP TMS] nets $11.4mm through registered direct ADS offering

[EDAP TMS SA] (high-intensity focused ultrasound for prostate cancer, and lithotripsy for urinary tract stones) netted $11.4mm through the registered direct offering of 3mm ordinary shares in the form of American Depositary Shares (ADSs) at $4, a 6%...

[Cardeas Pharma] closes $34mm Series B round

Three-year-old [Cardeas Pharma Corp.] (developing therapies for multi-drug-resistant bacterial infections) brought in $34mm in its Series B round led by first-time backer HIG BioVentures, which adds a board member. Other new investor Delphi Ventures...

Series A brings in $8.5mm for [Cardeas Pharma]

[Cardeas Pharma Corp.] (developing inhaled antibiotics for hospital-acquired respiratory infections) raised $8.5mm in its Series A financing led by Novo AS, which was joined by Avalon Ventures, Devon Park Bioventures, WRF Capital, and undisclosed pri...

[NPS Pharmaceuticals] nets $81.9mm via FOPO

[NPS Pharmaceuticals Inc.] (rare GI and endocrine diseases) netted $81.9mm through the follow-on public offering of 6mm common shares at $14.53.

Singh Brothers Deny Concealing Info From Daiichi Sankyo At Ranbaxy Sale

The Singh brothers who sold Ranbaxy Laboratories to Daiichi Sankyo denied accusations they concealed and misrepresented the status of a U.S. investigation of the company at the time of the sale.