Helius launches clinical trial; South Africa to regulate its med tech sector;

@FierceMedDev: VisionGate sets sights on FDA approval for noninvasive lung cancer Dx. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: HistoSonics raises $2M to develop its ultrasound-based ablation device. Article | Follow @VarunSaxena2

@EmilyWFierce: Cyndi Lauper says "no" to potato sacks in $NVS psoriasis campaign. More from FiercePharmaMarketing | Follow @EmilyWFierce

> Helius launched a Phase III clinical trial of its portable neuromodulation stimulator in conjunction with the U.S. Army Medical Research and Material Command. More

> South Africa is developing plans to regulate its medical device industry, which is currently unregulated. More

Biotech News

@FierceBiotech: We're looking for 2015's Fiercest women in biotech. More | Follow @FierceBiotech

@JohnCFierce: This is what happens when a company like $GSK fails at truly innovative R&D--you champion low risk, low margin stuff. More from FiercePharma | Follow @JohnCFierce

@DamianFierce: Why is the undervaluing never "arguable" or "marginal" or "if you really think about it?" More | Follow @DamianFierce

> Clovis pairs up with Roche on a high-profile immuno-oncology project. News

> Novavax offers hype and hope with an RSV 'breakthrough.' Article

> Baxalta's not swayed by Shire's 'lowball' $30B, CEO says. Story

> Adynxx eyes an IPO, late-stage program after pain drug clears a PhII hurdle. Article

Pharma News

@FiercePharma: Local funds behind Mevion Medical's $200M China JV aimed as country's first proton therapy system. More from FiercePharmaAsia | Follow @FiercePharma

@CarlyHFierce: Mallinckrodt amps up hospital business with $1.3B Therakos buy. ICYMI | Follow @CarlyHFierce

> CSL has 'money burning a hole in our pocket,' but it won't make premium deals. Item

> Advantage Brintellix? Lundbeck advances bid for cognitive label claim. Story

> Don't fall for Shire's 'lowball' bid, Baxalta CEO urges. Be true to our solo prospects instead. Article

Pharma Manufacturing News

> Feds indict Canada Drugs for sales of fake and foreign Avastin. More

> Boehringer Ingelheim recalls more than 358,000 inhalers. Report

> Bing to warn consumers about to land on illegal pharmacy sites. Item

> Daiichi Sankyo puts $80M into Tokyo vaccine plant. Story

> Taiwan pharma inspector arrested for taking drugmaker bribes. Article

Pharma Asia News

> HK-based Ally Bridge joins with WI Harper on $10M Cold Genesys Series B. Article

> U.S.-listed China Cord Blood soars on offer from China department store firm. More

> A new normal in China for pharmaceutical industry as reforms accumulate? Editor's corner

> Australia drug exports drop 30% as industry lobby group cites high manufacturing costs. Story

> U.S.-listed China Cord Blood soars on offer from China department store firm. Item

Drug Delivery News

> Galena launches Zuplenz nausea suppressor with MonoSol's oral film tech. Report

> Mannkind looking to use its inhaler in new therapeutic areas, not just diabetes. Item

> Liposomal drug delivery enters the spotlight in new Russian-U.S. report. Article

> Aerie to use GrayBug's delivery tech for sustained release of its ophthalmic candidates. Story

> Sanofi launches fast-acting, high-concentration insulin med Toujeo in the U.K. Article