Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Notizia

Food and Drug Administration repudiates ADHD drug by Sunovion Sunovion’s ADHD drug for the treatment of attention-deficit hyperactivity disorder (ADHD) has not been accepted by the Food and Drug Ad...

Sep 04, 2018

astellas
Commercial

NICE Rejects Gilead Sciences’ Yescarta on Cost Concerns The United Kingdom’s government-funded health service isn’t being so nice to Gilead Sciences’ CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for th...

Find More
cancer
Clinical

Use of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary. The FDA said sometimes the use of a placebo can present practical or ethical co...

Find More
FDA
AbbVie Receives Approval; Kymriah Approved; Shire Gets USFDA Approval; NICE Rejects; Bristol-Myers Squibb’s Opdivo; Eisai and Merck Get USFDA Approval

AbbVie Receives USFDA Approval for Imbruvica Plus Rituximab as First Chemotherapy-Free Combination Treatment for Waldenström's Macroglobulinemia Adults AbbVie announced that the USFDA approved Imbruvica (ibrutinib) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (W...

Find More

More Views & Analysis

Delveinsight
Outset Medical captures; Wright Medical Group to takeover Cartiva; Y-mAbs Therapeutics prepares for IPO; Biotech boom remunerates analysts

For all-in-one dialysis system, Outset Medical captures USD 132 Million to extend U.S. expansion Outset Medical bagged USD132 Million in series D capital. This ensued in encouraging the production capabilities and accelerating the commercial expansion for all-in-one dialysis system. The FDA cleared the Tablo Hemodia...

Find More

transthyretin amyloidosis
Notizia

Novartis sends out orphan disease drug to LifeMax Labs LifeMax Laboratories, biotech based in San Francisco is given an authorization of a treatment by Novartis for Netherton syndrome, an orphan genetic disorder. Focus of treatment is on managing symptoms and avoiding skin infections and other complications. Life...

Find More

Entasis
AZ dragout Entasis; Sierra remunerates Gilead; Principia raises; Harbour BioMed and Kelun pen deal

AstraZeneca dragout Entasis files to fund antibiotic phase 3 for USD 86 Million IPO Massachusetts-based Entasis Therapeutics has spun out to raise up to USD 86 Million through an IPO. The AstraZeneca spinout is attempting to fund a phase 3 trial of a drug to overcome bacterial resistance to beta-lactams. In 2015, ...

Find More

transthyretin amyloidosis
Kalydeco got approved; Opdivo for SCLC; FDA approved for pain relief; GC4419 obviates

Kalydeco, the first Cystic Fibrosis drug of Vertex, got approved for infants The Food and Drug Administration has cleared Kalydeco drug of Vertex Pharmaceuticals for infants aged 12 to under 24 months. The approved drug treats the underlying cause of cystic fibrosis in children of this age with at least one mutatio...

Find More

cancer
KEY CLINICAL OUTCOMES

Bexion Pharmaceuticals’ Early-Stage Cancer Drug, BXQ-350 Hailed as Game Changer For the Treatment of solid tumors and gliomas Bexion Pharmaceuticals’ investigational cancer treatment, BXQ-350, is receiving lots of mainstream media coverage as a potential game-changer. BXQ-350 is a formulation of a syntheticall...

Find More

FDA
Regulatory

Alnylam’s Onpattro Receives First-Ever US FDA Approval for Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults US FDA approved Alnylam’s Onpattro (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneurop...

Find More

Acromegaly is a rare, slowly progressive disorder that is caused when the pituitary glands produce t.....

Find More

A rare neurological disorder characterized by progressive weakness and impaired sensory function in .....

Find More

Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare acquired disease that leads to the destruction o.....

Find More

Halitosis is an oral health problem caused by volatile molecules which are formed because of patholo.....

Find More

Nestlé and Unilever are multinational corporations established in 1866 and 1930, respectively. The .....

Find More

RNAi is a fundamental gene-silencing pathway in eukaryotic cells, where long pieces of double-strand.....

Find More