Medical Dynamics

Fugitive pleads guilty in scheme (Deseret News)

FDA wants more data on Novartis’ COPD drug indacaterol (Pharma Times)

Novartis drug Tasigna(R) meets primary endpoint in pivotal trial against Gleevec(R) as first-line treatment in chronic myeloid leukemia patients (Reuters)

Read the rest of this entry »

New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid Arthritis (Reuters)
J&J, Schering Arthritis Drug Shows Success In Stopping Damage (Capitol.gr)
S&P: Pfizer Inc. Ratings Lowered To ‘AA’, Wyeth Issue Ratings Raised To ‘AA’, Both Off Watch (Pharma Live)

Read the rest of this entry »

New Pfizer up and running on day one, R&D cuts expected (PharmaTimes)
AstraZeneca’s Symbicort approved in Japan (Pharma Times)
CREON (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis (Pharma Live)

Read the rest of this entry »

Acorda Therapeutics Stock Trading Halted Today; FDA Advisory Committee to Review Fampridine-SR for Improvement
of Walking Ability in People with Multiple Sclerosis (Reuters)
Supreme Court to hear Teva-Proneuron dispute (Pink Sheet)

This is copyright protected information, to receive the full article, please click here to sign up and register.
Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR (Pharma Live)

Read the rest of this entry »

Development Corporation of Abilene Announces Management Agreement with Emergent Technologies, Inc (Reuters)

Solos Endoscopy, Inc.’s FDA Approved MammoView(TM) Product Line to Obtain CE (Reuters)

Read the rest of this entry »

Amaya Advisory Cmte. Will Grapple With Standards For Novel Indication (The Pink Sheet)

This is copyright protected information, to receive the full article, please click here to sign up and register.

Catalyst Pharmaceutical Partners, Inc. Announces Organizational Changes and Extension of Chief Executive’s Employment Agreement (Street Insider.com)

Novartis signs $465 million deal with Vanda on schizophrenia drug (Pharma Times)

Read the rest of this entry »

Influence Of Doctor/Pharma Relationships On Prescribing Habits May Be Next Big Congressional Inquiry; Sunshine Act Could Be Investigation Boon (The Pink Sheet)

 This is copyright protected information, to receive the full article, please click here to sign up and register.

Ahead of the Bell: Pharma Product Development Inc (CNBC/Associated  Press)

Selzentry Patient Population Needs Further Definition, Advisory Panel Urges (The Pink Sheet)

This is copyright protected information, to receive the full article, please click here to sign up and register.

Omeros Debuts With $68 Million IPO Despite Legal Hassles From Former CFO (The Pink Sheet)

This is copyright protected information, to receive the full article, please click here to sign up and register.

CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S. (Press release issued by CSL Behring)

Ex-biotech exec gets 3 years for faking cancer (Lake Wylie Pilot)

Celator(R) Pharmaceuticals Completes Enrollment Early in Phase 2 Study of CPX-351 in Newly Diagnosed AML (Press release issued by Celator Pharmaceuticals)

ImmuneRegen BioSciences to test efficacy of Homspera against H5N1 Avian Influenza (The Medical News)

Orion Genomics enters collaboration and license agreement with Novartis Pharma (The Medical News)

“Pfizer Halts Enrollment In Lung-Cancer Drug Trial” (Wall Street Journal)

Pfizer Inc. (PFE) has temporarily halted enrollment of new patients in a clinical trial of an experimental lung-cancer drug, saying the drug was associated with a higher rate of adverse events, including fatalities, than those who didn’t get the drug.

“J&J wheels and deals, awaits new product approvals” (Business Week)

Johnson & Johnson, the world’s biggest healthcare company and a Dow Jones industrial average component, reports earnings for the third quarter Tuesday morning. Here’s a summary of key developments and analyst opinion related to the period.

“Acorda shares plunge on negative FDA review”(AP)

Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that questioned the safety and effectiveness of the company’s multiple sclerosis drug.

“Omeros, First U.S. Biotech IPO Since February 2008, Sees Shares Drop 13 Percent in First Day” (Xconomy)

Shares of Seattle-based Omeros, the first true U.S. biotech company to go public in more than 18 months, dropped about 13 percent in the company’s first day of trading.

“Novartis snaps up first in class antibiotic” (PharmaTimes)

Swiss giant Novartis has snapped up the rights to market a potentially first-in-class antibiotic from Paratek Pharmaceuticals for an undisclosed sum, bolstering the company’s armamentarium in this field following its acquisition of Protez Pharmaceuticals in June last year.

“Nutra Pharma Announces Nyloxin Rx, a Prescription Analgesic for the Treatment of Severe (Stage 3) Chronic Pain” (Therapeutics Daily)

Nyloxin Rx is a prescription pain reliever produced by Nutra Pharma’s wholly-owned drug discovery subsidiary, ReceptoPharm. Unlike Stage 2 pain, which interferes with both work and sleep, Nyloxin Rx is aimed at treating Stage 3 pain, which is the most severe pain that inhibits one’s ability to fully function. Additionally, Nyloxin Rx does not rely on the use of opioids for its pain relieving action, but, instead, uses a novel mechanism from cobra venom peptides for treating pain.

“APP Pharmaceuticals Receives FDA Approval for Sumatriptan Succinate Injection” (Therapeutics Daily)

US-based pharmaceutical company APP Pharmaceuticals Inc, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals HoldingInc (NASDAQ: APCVZ), announced today that it has received approval from the US Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths.

Read the rest of this entry »