JOHNSON & JOHNSON LIKELY TO SHARE ITS COVID-19 VACCINE RESULTS NEXT WEEK

Highlights

• After announcing the results, the US pharmaceutical may apply for an emergency approval for its single-dose vaccine

• Johnson & Johnson CFO Joseph Wolk said “We plan to report out by early next week in terms of our results.”

&bu...

MODERNA SAYS ITS COVID VACCINE 94.5 % EFFICIENT, WILL SEEK US FDA'S EUA

Highlights

• Days after Pfizer and BioNTech reported over 90 percent efficacy of its COVID-19 vaccine candidate, biotechnology company Moderna announced results of its phase three trials

• Following its announcement, Moderna said it intends to submit the COVID-19 vac...

Pfizer COVID-19 VACCINE 90 PERCENT EFFECTIVE IN PHASE 3 TRIAL

Highlights

• Albert Bourla, Chairman and CEO of Pfizer said “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19.” 

• Pfizer said the results of its COVID-19 ...

ASTRAZENECA US COVID-19 VACCINE TRIAL LIKELY TO RESUME THIS WEEK

Highlights

• Late-stage US trial of AstraZeneca's COVID-19 vaccine were put on hold since September 6 after a participant in the company’s UK trial fell ill with a suspiciously rare spinal inflammatory disorder known as transverse myelitis

• Sources claim t...

ANTI-DIABETES DRUG METFORMIN RECALLED OVER DOUBTS OF CONTAINING CANCER-CAUSING COMPOUND

Highlights

• The USFDA has previously released an alert in the month of May, where it had stated agency laboratory testing of several lots of extended-release (ER) metformin revealed levels of N-Nitrosodimethylamine (NDMA) above prescribed limit

• Metformin, a drug u...

AstraZeneca COVID-19 VACCINE TRIAL STILL ON HOLD IN THE U.S.: HHS ALEX AZAR

Highlights

• Immediately after one of the participants in the UK had reported serious adverse reaction, the clinical trials of AstraZeneca's COVID-19 vaccine, called AZD1222 were put on hold on September 6

• Azar clearly said that the trials for AstraZeneca&rsquo...

PFIZER CONFIDENT ABOUT EFFECTIVENESS OF ITS COVID-19 VACCINE CANDIDATE

Highlights

• This American pharmaceutical company in last weeks has said it should know by the end of October whether their COVID-19 vaccine is safe and effective

• Pfizer's protocol is submitted to the FDA for review and is being overseen by Data and Safety Moni...

ZYDUS CADILA GETS USFDA APPROVAL FOR POTASSIUM CHLORIDE EXTENDED RELEASE TABLETS

Highlights

• Zydus Cadila, part of Cadila Healthcare group in a BSE filing said it has received final approval from the United States Food and Drug Administration (USFDA) in order to market Potassium Chloride extended release tablets in the strengths of 10 mEq (750 mg) and 20 mEq (...

AERIE PHARMACEUTICALS' IRELAND FACILITY RECEIVES USFDA APPROVAL

Highlights

• Vicento Anido, Jr. Ph.D., Chairman and Chief Executive Officer (CEO) at Aerie Pharmaceuticals said the PAS approval for Rhopressa represents another important manufacturing achievement for the company in the year 2020

• Aerie expects to begin shipping Rh...

ZYDUS CADILA GETS USFDA APPROVAL TO MARKET DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION

Highlights

• Zydus Cadila in the statement issued on Friday said that it has received final approval from the USFDA to market Doxorubicin Hydrochloride Liposome injection in the strengths of 20 mg/10 mL (2mg/mL) and 50 mg/25 mL (2mg/mL) single-dose vials

• Zydus Casu...

ALEMBIC PHARMA'S ARM GETS USFDA TENTATIVE APPROVAL FOR DRUG TO TREAT PAH

Highlights

• Pulmonary arterial hypertension (PAH) affects arteries in the lungs and in the heart

• As per the reports, this newly approved drug is therapeutically equivalent to the reference listed drug product Remodulin injection which has been developed by United ...

COVID-19 VACCINE COULD BE AVAILABLE EARLIER THAN EXPECTED SAYS DR. FAUCI

Highlights

• Dr. Anthony Fauci said the COVID-19 vaccine could be available earlier than expected if the ongoing human clinical trials produce overwhelmingly positive results

• The Data and Safety Monitoring Board has all the rights to end the ongoing vaccine trials&...

COVID-19 VACCINE: USFDA CHIEF PROMISES REVIEW OF VACCINE WILL BE TRANSPARENT

Highlights

• Development of COVID-19 vaccine before the elections is extremely important for the U.S. President Donald Trump

• Dr Stephen Hahn was appointed by Trump in late 2019

• The USFDA has not made any decision as of now and has not seen any tria...

9.71 BOTTLES OF METFORMIN HYDROCHLORIDE IN U.S. RECALLED BY LUPIN, GRANULES INDIA

Pharmaceutical companies Lupin and Granules India are presently recalling nearly 9.71 lakh bottles of generic diabetes drug in the United States in wake of the possibility of the affected lot contains cancer inducing nitrosodimethylamine (NDMA) above the acceptable intake limit. 
Acco...

SANTEN OBTAINS US FDA ACCEPTANCE OF PMA APPLICATION FOR DE-128

HIGHLIGHTS

• Santen Pharmaceutical Co., Ltd. has submitted the Premarket Approval (PMA) application for DE-128 (MicroShunt) for review.
• US FDA has accepted the application from Santen.
• DE-128 is an investigational surgical glaucoma implant.

GLENMARK PHARMA RECEIVES USFDA APPROVAL FOR FINGOLIMOD CAPSULES, 0.5 MG

Highlights

• USFDA has given green signal for the production of Fingomolid Capsules that are used in treatment of relapsed form of multiple sclerosis in adults

• At present, Glenmark's portfolio comprises of 164 products authorized for distribution in the US mark...

JOHNSON & JOHNSON STOPS SELLING BABY POWDER IN THE U.S. AND CANADA

Highlights

• Johnson & Johnson will continue selling its talc-based baby powder in other countries

• Nearly 19,400 petitioners had filed lawsuits against Johnson & Johnson

• In 2019, 33,000 bottles of talc-based baby powder were called back by ...

FDA PLANNING TO AUTHORIZE USE OF REMDESIVIR FOR COVID-19

Some good news regarding the possible treatment for coronavirus was brought in by the researchers and medical experts. According to the researchers, there are evidences which show effectiveness of the experimental drug remdesivir as it might help COVID-19 patients recover quickly.
Ever sin...

SURGLASSES Foresee-X Augment Reality Treatment Registered with the FDA and Designed for Trauma

Foresee-X is a set of advanced surgical glasses focused on augmented and mixed reality technology with features. SURGLASSES offered Foresee-X for clinical approval to many surgeons and hospitals, and the medical community warmly welcomed the drug. Recognizing the strong potential demand for Fores...

Granules gets an approval from USFDA for allergy treating drug

Based in Hyderabad, the Indian pharmaceutical manufacturing company, Granules India Limited announced the approval for Fexofenadine Hydrochloride tablets from the US Health regulator.

The tablet is allegedly used for treating allergy symptoms. According to sources, the tablets are bio-e...