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11 Jul 2020

DCGI approved Itolizumab to treat COVID-19 patients with moderate to severe acute respiratory distress

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India’s drug regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for “restricted emergency use” to treat...

5 Jun 2020

Aurobindo Pharma hives off its biosimilars business to subsidiary CuraTeQ Biologics

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TagsAurobindo, Biosimilar, CuraTeQ Biologics

Aurobindo Pharma hives off its biosimilars business to wholy-owned subsidiary ‘CuraTeQ Biologics Private Limited’ for a cash consideration of ₹361.46...

5 Jun 2020

Lupin, Mylan receive EUmarketing authorization for Nepexto

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Lupin Limited (Lupin) and Mylan N.V. announced that the European Commission (EC) has granted marketing authorization for Nepexto, a biosimilar...

5 Jun 2020

AstraZeneca, Accent Therapeutics partners to develop transformative therapeutics targeting RMPs to treat cancer

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TagsAccent Therapeutics, AstraZeneca, codevelopment deal in pharma

Accent Therapeutics and AstraZeneca forged a collaboration valued at about $1.1 billion to discover, develop and commercialize transformative therapeutics targeting...

5 Jun 2020

Roche’s Elecsys IL-6 test received USFDA EUA

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TagsCOVID-19, Roche, USFDA emergency use authorization

Roche announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys...

13 May 2020

Gilead’s Voluntary Licensing Agreements for Remdesivir with 5 generic companies

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Tagsdrug licensing, gilead, global pharma licensing deal, licensing deal in pharma, mylan licensing deal, nonexclusive, Remdesivir

Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply...

7 May 2020

Market Exclusivity Case Study: XIFAXAN (rifaximin)

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Tags505(j) ANDA, ANDA, Bausch, MARKET EXCLUSIVITY, Patent infringement case, sandoz

Bausch Health Companies Inc. along with its wholly owned subsidiary, Salix Pharmaceuticals, which is one of the largest specialty pharmaceutical...

7 May 2020

FDA Grants Accelerated Approval to Capmatinib for NSCLC

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The FDA granted accelerated approval to capmatinib (Tabrecta) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors...

7 May 2020

Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility

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Tags483, 483 observations, Alembic, Aleor Dermaceuticals, EIR

Aleor Dermaceuticals Ltd. (Aleor), a 60:40 joint venture between Alembic Pharmaceuticals Ltd. (Alembic) and Orbicular Pharmaceutical Technologies Pvt. Ltd. (Orbicular),...

7 May 2020

Lupin introduces ‘Jan Kovid’ helpline for Mumbai citizens

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Lupin has announced the launch of the ‘Jan Kovid’ Helpline (1800-572-6130) under the tagline ‘Mann Ka Swaasthya, Tann Ki Suraksha’ for...

7 May 2020

Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar

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TagsBausch + Lomb, Ranibizumab, Ranibizumab biosimilar, Stada, Xbrane Signs Deal With Helvetic BioPharma for its Lead Ranibizumab Biosimilar

Bausch + Lomb announced an exclusive licensing agreement with Stada Arzneimittel and its development partner Xbrane Biopharma to develop and...

5 May 2020

Valneva And Pfizer to Co-Develop and Commercialize Lyme Disease Vaccine, Vla15

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Tagspfizer, Valneva

Valneva SE, a specialty vaccine company, and Pfizer Inc. today announced a collaboration to develop and commercialize Valneva’s Lyme disease...

5 May 2020

Ipsen agreement with IRICoR & Université de Montréal to acquire exclusive license for discovery-stage oncology programme

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TagsDrug Discovery and Development Pathway, Ipsen

Ipsen, a global specialty-driven biopharmaceutical group, IRICoR, a pan-Canadian research commercialization center focused on drug discovery, and Université de Montréal,...

24 Apr 2020

Global Licensing Agreement Case study: ProThera Biologics and Takeda to Develop Novel Plasma-Derived Therapy Based on Inter-alpha Inhibitor Proteins (IAIP)

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Tagscodevelopment deal in pharma, licensing deal in pharma, ProThera Biologics, Takeda

ProThera Biologics, Inc. and Takeda Pharmaceutical Company Limited have entered into a global licensing agreement to develop a novel plasma-derived...

24 Apr 2020

Glenmark Foundation rolls out tele-health solution to expand access to quality patient care

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TagsCSR campaign in pharma

Glenmark Foundation, the CSR arm of Glenmark Pharmaceuticals along with its NGO partners, has launched a tele-health solution in partnership...

24 Apr 2020

Florio GmbH introducing new digital platform aiming to improve the lives of people with haemophilia

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Tagsdigital marketing in pharma

Swedish Orphan Biovitrum AB (publ) (Sobi) has announced the launch by its affiliate, Florio GmbH, of Florio, a digital medical...

8 Apr 2020

Gilead Sciences, Second Genome ink collaboration strategic deal in biomarker and inflammatory bowel disease drug discovery

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Tagsgilead, Gilead Sciences, Strategic deal in pharma

Gilead Sciences, Inc and Second Genome, a leader in microbiome science, announced that the companies have entered into a four-year...

7 Apr 2020

Who determines when a prescription medicine should be switched to OTC status?

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TagsBenadryl rx to otc switch, OTC drugs, otc monograph, Rx to otc switch, what is OTC monograph?

Technically, anyone could submit a Citizen’s Petition to FDA to switch a product from Rx to OTC status. However, the...

7 Apr 2020

What is the difference between purity and potency?

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Tagspotency, purity

Purity means relative freedom from extraneous matter in the finished product, whether or not harmful to the recipient or deleterious...

7 Apr 2020

Case Study: US FDA approves erythroid maturation agent, Reblozyl

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TagsAcceleron Pharma, BMS, Reblozyl

Bristol Myers Squibb and Acceleron Pharma Inc, a biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved...

6 Apr 2020

Case Study: Compassionate use of remdesivir of Gilead for COVID-19

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Tagscompassionate use, Expanded access, expanded access compassionate use, gilead, Gilead Sciences

During an extraordinary virtual meeting held on April 2, 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the...

3 Apr 2020

Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China

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TagsJapan drug regulatory affairs

Eisai Co Ltd and Seikagaku Corporation, an R&D-oriented pharmaceutical company, announced that the companies have entered into an agreement for...

3 Apr 2020

Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.

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TagsDPCO, medical device company, NPPA, price regulation in india, Price regulation of medical devices

The central government on Tuesday notified all medical devices sold in the country will be treated as drugs under the...

29 Mar 2020

Evox partnership with Takeda Pharmaceutical for rare disease

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Tagsorphan drug, orphan drug design, rare disease, Takeda

Evox Therapeutics Ltd, a leading exosome therapeutics company, announced the signing of a rare disease-focused partnership with Takeda Pharmaceutical Company...

27 Mar 2020

What are the difference between FDA 483 and Warning Letter?

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Tags483, 483 observations, fda 483 observation, usfda 483 form, USFDA warning letter, warning

483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form...

26 Mar 2020

New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19

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Tagscase study of new drug approval, new drug approval, Ozanimod

U.S. Food and Drug Administration (FDA) has approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms...

26 Mar 2020

AstraZeneca and Silence Therapeutics co-development siRNA therapeutics

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TagsAstraZeneca, codevelopment deal in pharma, global pharma deals

AstraZeneca will collaborate with Silence Therapeutics to discover, develop and commercialise small interfering RNA (siRNA) therapeutics for the treatment of...

21 Mar 2020

US FDA halts the regular plant inspection due to Covid-19 spread

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TagsUSFDA inspection

The US FDA announced that it will no longer be able to inspect domestic production facilities in wake of risk...

21 Mar 2020

Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older

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TagsEpclusa, gilead, Gilead Sciences, Gilead's Sofosbuvir, Meaning of supplemental new drug application (snda), What is supplemental new drug application (snda)?

US FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for...

21 Mar 2020

A case based understanding in co-development deal

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Tagsco-development deal, drug licensing, inlicensing in pharma, outlicensing in pharma, Pfizer and Merck KGaA to co-develop and co-commercialize avelumab

In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well,...

Recently Published Articles

DCGI approved Itolizumab to treat COVID-19 patients with moderate to severe acute respiratory distress

Aurobindo Pharma hives off its biosimilars business to subsidiary CuraTeQ Biologics

Lupin, Mylan receive EUmarketing authorization for Nepexto

AstraZeneca, Accent Therapeutics partners to develop transformative therapeutics targeting RMPs to treat cancer

Roche’s Elecsys IL-6 test received USFDA EUA

Gilead’s Voluntary Licensing Agreements for Remdesivir with 5 generic companies

Market Exclusivity Case Study: XIFAXAN (rifaximin)

FDA Grants Accelerated Approval to Capmatinib for NSCLC

Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility

Lupin introduces ‘Jan Kovid’ helpline for Mumbai citizens

Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar

Valneva And Pfizer to Co-Develop and Commercialize Lyme Disease Vaccine, Vla15

Ipsen agreement with IRICoR & Université de Montréal to acquire exclusive license for discovery-stage oncology programme

Global Licensing Agreement Case study: ProThera Biologics and Takeda to Develop Novel Plasma-Derived Therapy Based on Inter-alpha Inhibitor Proteins (IAIP)

Glenmark Foundation rolls out tele-health solution to expand access to quality patient care

Florio GmbH introducing new digital platform aiming to improve the lives of people with haemophilia

Gilead Sciences, Second Genome ink collaboration strategic deal in biomarker and inflammatory bowel disease drug discovery

Who determines when a prescription medicine should be switched to OTC status?

What is the difference between purity and potency?

Case Study: US FDA approves erythroid maturation agent, Reblozyl

Case Study: Compassionate use of remdesivir of Gilead for COVID-19

Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China

Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.

Evox partnership with Takeda Pharmaceutical for rare disease

What are the difference between FDA 483 and Warning Letter?

New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19

AstraZeneca and Silence Therapeutics co-development siRNA therapeutics

US FDA halts the regular plant inspection due to Covid-19 spread

Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older

A case based understanding in co-development deal

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